A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02617784
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Drug: Oseltamivir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Center, Open Label, Multiple-Dose Oral Oseltamivir Suspension Study in End-Stage-Renal Disease (ESRD) Patients on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Jun 1, 2002
• Actual Study Completion Date: Jun 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A: Oseltamivir with HD Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir.	Drug: Oseltamivir; Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.; Other Names: Tamiflu
Experimental: Regimen B: Oseltamivir with CAPD Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.	Drug: Oseltamivir; Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.; Other Names: Tamiflu

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).

2. Cmax of Oseltamivir in HD Participants During Days 38 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose]

   Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

3. Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

4. Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

5. Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).

6. AUC of Oseltamivir in HD Participants During Days 38 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.

7. AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.

8. AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.

9. Cmax of Oseltamivir in CAPD Participants During Days 1 to 6 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose]

   Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

10. Cmax of Oseltamivir in CAPD Participants During Days 36 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose]

    Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

11. Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

12. Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose]

    Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.

13. AUC of Oseltamivir in CAPD Participants During Days 1 to 6 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.

14. AUC of Oseltamivir in CAPD Participants During Days 36 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose]

    Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.

15. AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.

16. AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43 [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose]

    Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.

Secondary Outcome Measures

1. Plasma Concentration of Oseltamivir by Timepoint in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.

2. Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.

3. Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.

4. Tmax of Metabolite Oseltamivir Carboxylate in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose]

   Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.

5. Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants [Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose]

   Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).

6. CL/F of Metabolite Oseltamivir Carboxylate in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose]

   Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.

7. Renal Clearance (CLr) of Oseltamivir in HD Participants [Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose]

   Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.

8. CLr of Metabolite Oseltamivir Carboxylate in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose]

   Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.

9. Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants [Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40]

   Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.

10. Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants [Urine samples 0 to 42 hours from D1 dose]

    Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

11. Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants [Urine samples 0 to 42 hours from D1 dose]

    Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

12. Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants [Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40]

    Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.

13. Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.

14. Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose]

    Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.

15. Tmax of Oseltamivir in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.

16. Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.

17. Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).

18. Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose]

    Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.

19. CL/F of Oseltamivir in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose]

    Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.

20. CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose]

    Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.

21. CLr of Oseltamivir in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose]

    Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.

22. CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose]

    Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.

23. CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants [Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose]

    Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.

24. Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants [Urine samples 0 to 48 hours from D1 dose]

    Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

25. Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants [Urine samples 0 to 48 hours from D1 dose]

    Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

26. Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants [Dialysate samples 0 to 48 hours from D1 dose]

    Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

27. Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants [Dialysate samples 0 to 48 hours from D1 dose]

    Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults greater than or equal to (>/=) 18 years of age

• ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (<) 10 milliliters per minute (mL/min)

• Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10 mL/min

• Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2)

• Use of contraception among women of childbearing potential

Exclusion Criteria:

• Clinical significant comorbid disease or terminal illness

• Known human immunodeficiency virus (HIV) or hepatitis B or C

• History of drug or alcohol abuse within the prior year

• Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to Screening

• Participation in a clinical study with an investigational drug in the 3 months prior to study drug

• Pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Christchurch		New Zealand	8011

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02617784
• Other Study ID Numbers: NP16472
• First Posted: Dec 1, 2015
• Last Update Posted: Feb 15, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Oseltamivir

Study Results

Participant Flow

Arm/Group Title	Oseltamivir With HD	Oseltamivir With CAPD
Arm/Group Description	Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.	Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Period Title: Overall Study
STARTED	12	12
First Dose Assessment Period	12	12
Second Dose Assessment Period	11	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oseltamivir With HD	Oseltamivir With CAPD	Total
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.00 (13.23)	54.42 (14.30)	51.21 (13.87)
Sex: Female, Male (Count of Participants)
Female	1 8.3%	7 58.3%	8 33.3%
Male	11 91.7%	5 41.7%	16 66.7%

Outcome Measures

1. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	20.2 (12.3)

2. Primary Outcome

Title	Cmax of Oseltamivir in HD Participants During Days 38 to 43
Description	Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	11
Mean (Standard Deviation) [ng/mL]	22.6 (9.69)

3. Primary Outcome

Title	Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	943 (393)

4. Primary Outcome

Title	Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
Description	Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	11
Mean (Standard Deviation) [ng/mL]	1120 (320)

5. Primary Outcome

Title	Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
AUC12	63.9 (24.6)
AUClast	62.1 (26.8)

6. Primary Outcome

Title	AUC of Oseltamivir in HD Participants During Days 38 to 43
Description	Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	11
AUC12	68.5 (19.5)
AUClast	65.6 (20.1)

7. Primary Outcome

Title	AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
AUC42	31600 (14100)
AUClast	44400 (19000)

8. Primary Outcome

Title	AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
Description	Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	11
AUC42	38200 (11500)
AUClast	60400 (16700)

9. Primary Outcome

Title	Cmax of Oseltamivir in CAPD Participants During Days 1 to 6
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	32.0 (20.4)

10. Primary Outcome

Title	Cmax of Oseltamivir in CAPD Participants During Days 36 to 43
Description	Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	27.7 (15.9)

11. Primary Outcome

Title	Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	885 (244)

12. Primary Outcome

Title	Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
Description	Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	849 (200)

13. Primary Outcome

Title	AUC of Oseltamivir in CAPD Participants During Days 1 to 6
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
AUC12	85.6 (40.7)
AUClast	78.5 (41.8)

14. Primary Outcome

Title	AUC of Oseltamivir in CAPD Participants During Days 36 to 43
Description	Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
AUC12	72.4 (28.3)
AUClast	67.7 (27.7)

15. Primary Outcome

Title	AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
AUC48	33400 (9700)
AUClast	56800 (18300)

16. Primary Outcome

Title	AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
Description	Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (Second Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
AUC48	32400 (8210)
AUClast	60800 (18800)

17. Secondary Outcome

Title	Plasma Concentration of Oseltamivir by Timepoint in HD Participants
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
0 hours from D1 dose (n=12)	0 (0)
1 hour from D1 dose (n=12)	18.0 (14.2)
2 hours from D1 dose (n=12)	12.5 (6.58)
4 hours from D1 dose (n=12)	6.06 (2.37)
8 hours from D1 dose (n=12)	1.93 (1.64)
12 hours from D1 dose (n=12)	0.513 (0.783)
20 hours from D1 dose (n=12)	0.104 (0.361)
32 hours from D1 dose (n=12)	0.0 (0.0)
42 hours from D1 dose (n=12)	0.0 (0.0)
48 hours from D1 dose (n=12)	0.0 (0.0)
49 hours from D1 dose (n=12)	0.0 (0.0)
90 hours from D1 dose (n=12)	0.0 (0.0)
0 hours from D38 dose (n=11)	0.413 (0.938)
1 hour from D38 dose (n=11)	21.5 (9.96)
2 hours from D38 dose (n=11)	15.4 (5.98)
4 hours from D38 dose (n=11)	6.07 (2.80)
8 hours from D38 dose (n=11)	1.30 (0.801)
12 hours from D38 dose (n=11)	0.193 (0.429)
20 hours from D38 dose (n=11)	0.0 (0.0)
32 hours from D38 dose (n=11)	0.0 (0.0)
42 hours from D38 dose (n=11)	0.0 (0.0)
48 hours from D38 dose (n=11)	0.0 (0.0)
49 hours from D38 dose (n=11)	0.0 (0.0)
114 hours from D38 dose (n=11)	0.0 (0.0)

18. Secondary Outcome

Title	Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
Description	Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included at specified timepoints in the analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
0 hours from D1 dose (n=12)	0.908 (3.15)
1 hour from D1 dose (n=12)	25.7 (24.5)
2 hours from D1 dose (n=12)	107 (83.7)
4 hours from D1 dose (n=12)	276 (181)
8 hours from D1 dose (n=12)	589 (321)
12 hours from D1 dose (n=12)	772 (363)
20 hours from D1 dose (n=12)	908 (383)
32 hours from D1 dose (n=12)	926 (399)
42 hours from D1 dose (n=12)	877 (393)
48 hours from D1 dose (n=12)	212 (78.6)
49 hours from D1 dose (n=12)	233 (88.2)
90 hours from D1 dose (n=12)	240 (123)
0 hours from D38 dose (n=11)	59.0 (32.1)
1 hour from D38 dose (n=11)	95.0 (32.8)
2 hours from D38 dose (n=11)	200 (58.7)
4 hours from D38 dose (n=11)	413 (137)
8 hours from D38 dose (n=11)	745 (239)
12 hours from D38 dose (n=11)	933 (295)
20 hours from D38 dose (n=11)	1090 (327)
32 hours from D38 dose (n=11)	1080 (328)
42 hours from D38 dose (n=11)	1050 (340)
48 hours from D38 dose (n=11)	263 (61.4)
49 hours from D38 dose (n=11)	279 (66.4)
114 hours from D38 dose (n=11)	283 (112)

19. Secondary Outcome

Title	Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
Description	Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included in the specific dose analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Days 1 to 5 (n=12)	1.75 (1.14)
Days 38 to 43 (n=11)	1.18 (0.40)

20. Secondary Outcome

Title	Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
Description	Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included in the specific dose analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Days 1 to 5 (n=12)	29.7 (8.0)
Days 38 to 43 (n=11)	29.2 (9.61)

21. Secondary Outcome

Title	Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
Description	Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).
Time Frame	Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included in the specific dose analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Days 1 to 5 (n=12)	677 (727)
Days 38 to 43 (n=11)	474 (141)

22. Secondary Outcome

Title	CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
Description	Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included in the specific dose analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Days 1 to 5 (n=12)	1.20 (1.05)
Days 38 to 43 (n=11)	0.779 (0.239)

23. Secondary Outcome

Title	Renal Clearance (CLr) of Oseltamivir in HD Participants
Description	Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [L/h]	0.0521 (0.133)

24. Secondary Outcome

Title	CLr of Metabolite Oseltamivir Carboxylate in HD Participants
Description	Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [L/h]	0.0203 (0.0568)

25. Secondary Outcome

Title	Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
Description	Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40

Outcome Measure Data

Analysis Population Description

PK Analysis Population; n = number of participants included in the specific dose analysis.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Days 1 to 5 (n=12)	7.42 (0.447)
Days 38 to 43 (n=11)	8.43 (3.02)

26. Secondary Outcome

Title	Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants
Description	Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Urine samples 0 to 42 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of oseltamivir dose]	0.00982 (0.0221)

27. Secondary Outcome

Title	Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants
Description	Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Urine samples 0 to 42 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of osteltamivir dose]	1.86 (4.66)

28. Secondary Outcome

Title	Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Description	Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Time Frame	Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With HD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
Measure Participants	12
Arterial: 1 hour (Day 3)	570 (229)
Arterial: 2 hours (Day 3)	412 (157)
Arterial: 4 hours (Day 3)	227 (82.2)
Arterial: 5 hours (Day 3)	171 (61.8)
Venous: 1 hour (Day 3)	284 (121)
Venous: 2 hours (Day 3)	202 (74.4)
Venous: 4 hours (Day 3)	127 (69.1)
Venous: 5 hours (Day 3)	84.3 (29.6)
Arterial: 1 hour (Day 40)	666 (179)
Arterial: 2 hours (Day 40)	496 (125)
Arterial: 4 hours (Day 40)	281 (58.8)
Arterial: 5 hours (Day 40)	218 (45.6)
Venous: 1 hour (Day 40)	317 (103)
Venous: 2 hours (Day 40)	229 (69.6)
Venous: 4 hours (Day 40)	128 (37.3)
Venous: 5 hours (Day 40)	95.4 (27.7)

29. Secondary Outcome

Title	Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
0 hours from D1 dose	0.0 (0.0)
1 hour from D1 dose	27.8 (21.9)
2 hours from D1 dose	22.6 (12.6)
4 hours from D1 dose	6.98 (2.70)
8 hours from D1 dose	0.630 (0.833)
12 hours from D1 dose	0.100 (0.346)
24 hours from D1 dose	0.0 (0.0)
48 hours from D1 dose	0.0 (0.0)
72 hours from D1 dose	0.0 (0.0)
120 hours from D1 dose	0.0 (0.0)
0 hours from D36 dose	0.0 (0.0)
1 hour from D36 dose	24.8 (16.8)
2 hours from D36 dose	18.0 (8.88)
4 hours from D36 dose	5.78 (2.09)
8 hours from D36 dose	0.754 (0.705)
12 hours from D36 dose	0.103 (0.358)
24 hours from D36 dose	0.0 (0.0)
48 hours from D36 dose	0.0 (0.0)
72 hours from D36 dose	0.0 (0.0)
120 hours from D36 dose	0.0 (0.0)
168 hours from D36 dose	0.0 (0.0)

30. Secondary Outcome

Title	Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
Description	Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
0 hours from D1 dose	0.0 (0.0)
1 hour from D1 dose	20.3 (19.9)
2 hours from D1 dose	121 (72.7)
4 hours from D1 dose	381 (171)
8 hours from D1 dose	691 (217)
12 hours from D1 dose	812 (251)
24 hours from D1 dose	879 (245)
48 hours from D1 dose	580 (193)
72 hours from D1 dose	360 (148)
120 hours from D1 dose	147 (80.9)
0 hours from D36 dose	69.2 (40.1)
1 hour from D36 dose	97.0 (52.3)
2 hours from D36 dose	184 (84.7)
4 hours from D36 dose	403 (149)
8 hours from D36 dose	663 (179)
12 hours from D36 dose	802 (200)
24 hours from D36 dose	831 (201)
48 hours from D36 dose	563 (172)
72 hours from D36 dose	362 (138)
120 hours from D36 dose	149 (71.6)
168 hours from D36 dose	63.0 (38.1)

31. Secondary Outcome

Title	Tmax of Oseltamivir in CAPD Participants
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	1.50 (0.52)
Days 36 to 43	1.28 (0.0470)

32. Secondary Outcome

Title	Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	20.0 (5.91)
Days 36 to 43	19.0 (6.18)

33. Secondary Outcome

Title	Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	0.0211 (0.00578)
Days 36 to 43	0.0200 (0.00488)

34. Secondary Outcome

Title	Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	34.8 (8.39)
Days 36 to 43	36.3 (7.53)

35. Secondary Outcome

Title	CL/F of Oseltamivir in CAPD Participants
Description	Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	424 (183)
Days 36 to 43	485 (215)

36. Secondary Outcome

Title	CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population.

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Days 1 to 6	0.882 (0.250)
Days 36 to 43	0.898 (0.246)

37. Secondary Outcome

Title	CLr of Oseltamivir in CAPD Participants
Description	Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [L/h]	0.146 (0.250)

38. Secondary Outcome

Title	CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [L/h]	0.0665 (0.114)

39. Secondary Outcome

Title	CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.
Time Frame	Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [L/h]	0.425 (0.0456)

40. Secondary Outcome

Title	Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants
Description	Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Urine samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of oseltamivir dose]	0.0290 (0.0490)

41. Secondary Outcome

Title	Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Urine samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of oseltamivir dose]	6.44 (10.8)

42. Secondary Outcome

Title	Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants
Description	Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Dialysate samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of oseltamivir dose]	0.00367 (0.0127)

43. Secondary Outcome

Title	Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants
Description	Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Time Frame	Dialysate samples 0 to 48 hours from D1 dose

Outcome Measure Data

Analysis Population Description

PK Analysis Population (First Dose Subpopulation).

Arm/Group Title	Oseltamivir With CAPD
Arm/Group Description	Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
Measure Participants	12
Mean (Standard Deviation) [percentage of oseltamivir dose]	32.6 (8.77)

Adverse Events

Time Frame	From Day 1 to 43 and up to 14 days after last PK assessment (up to approximately 57 days total)
Adverse Event Reporting Description	Safety Population
Arm/Group Title	Oseltamivir With HD		Oseltamivir With CAPD
Arm/Group Description	Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.		Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
All Cause Mortality
	Oseltamivir With HD		Oseltamivir With CAPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Oseltamivir With HD		Oseltamivir With CAPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		2/12 (16.7%)
Cardiac disorders
Angina unstable	1/12 (8.3%)		0/12 (0%)
Pericarditis not otherwise specified	0/12 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Peritonitis	0/12 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Coccydynia	0/12 (0%)		1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	Oseltamivir With HD		Oseltamivir With CAPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/12 (66.7%)		10/12 (83.3%)
Blood and lymphatic system disorders
Anaemia not otherwise specified	0/12 (0%)		1/12 (8.3%)
Anaemia not otherwise specified, aggravated	0/12 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Vomiting not otherwise specified	1/12 (8.3%)		3/12 (25%)
Nausea	2/12 (16.7%)		1/12 (8.3%)
Peritonitis	0/12 (0%)		3/12 (25%)
Diarrhoea not otherwise specified	1/12 (8.3%)		1/12 (8.3%)
Constipation	0/12 (0%)		1/12 (8.3%)
Dyspepsia	1/12 (8.3%)		0/12 (0%)
Mouth ulceration	1/12 (8.3%)		0/12 (0%)
General disorders
Dizziness (excluding vertigo)	2/12 (16.7%)		0/12 (0%)
Malaise	0/12 (0%)		2/12 (16.7%)
Fatigue	1/12 (8.3%)		0/12 (0%)
Haemorrhage not otherwise specified	1/12 (8.3%)		0/12 (0%)
Injection site pain	0/12 (0%)		1/12 (8.3%)
Pain in jaw	0/12 (0%)		1/12 (8.3%)
Hepatobiliary disorders
Hepatic function abnormal not otherwise specified	0/12 (0%)		1/12 (8.3%)
Infections and infestations
Blood culture positive	0/12 (0%)		1/12 (8.3%)
Herpes zoster	0/12 (0%)		1/12 (8.3%)
Urinary tract infection not otherwise specified	0/12 (0%)		1/12 (8.3%)
Vaginitis	0/12 (0%)		1/12 (8.3%)
Vaginosis bacterial not otherwise specified	0/12 (0%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Skin injury not otherwise specified	0/12 (0%)		1/12 (8.3%)
Investigations
Haemoglobin decreased	0/12 (0%)		1/12 (8.3%)
Metabolism and nutrition disorders
Appetite decreased	0/12 (0%)		1/12 (8.3%)
Calcification metastatic	1/12 (8.3%)		0/12 (0%)
Gout	1/12 (8.3%)		0/12 (0%)
Hypokalaemia	0/12 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/12 (0%)		2/12 (16.7%)
Myalgia	0/12 (0%)		1/12 (8.3%)
Neck pain	1/12 (8.3%)		0/12 (0%)
Nervous system disorders
Headache not otherwise specified	4/12 (33.3%)		4/12 (33.3%)
Psychiatric disorders
Depression not otherwise specified	0/12 (0%)		1/12 (8.3%)
Renal and urinary disorders
Haematuria	1/12 (8.3%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Sinus congestion	0/12 (0%)		1/12 (8.3%)
Sneezing	0/12 (0%)		1/12 (8.3%)
Sore throat not otherwise specified	1/12 (8.3%)		0/12 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1/12 (8.3%)		1/12 (8.3%)
Skin disorder not otherwise specified	0/12 (0%)		1/12 (8.3%)
Tongue oedema	1/12 (8.3%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.