A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01382212
• Collaborator: (none)
• Enrollment: 13
• Arm: 1
• Duration (Months): 42

Study Details

Study Description

Brief Summary

The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Renal Disease; Secondary Hyperparathyroidism	Drug: paricalcitol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Paricalcitol Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Drug: paricalcitol; Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.; Other Names: ABT-358, Zemplar

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Hypercalcemia [Day 1 to Week 12]

   The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).

Secondary Outcome Measures

1. Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL [Baseline (last measurement collected prior to the first dose) to Week 12]

2. Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline [Baseline (last measurement collected prior to the first dose) to Week 12]

3. Hemoglobin: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

4. Hematocrit: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

5. Red Blood Cells: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

6. White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

7. Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

8. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

   n=subjects with evaluable Baseline and Post-baseline data for each parameter.

9. Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

   n=subjects with evaluable Baseline and Post-baseline data for each parameter.

10. Alkaline Phosphatase: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

11. Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

12. Total Protein and Albumin: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

13. Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

14. Osteocalcin: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

15. Number of Subjects With Adverse Events [From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).]

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

16. Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings [Baseline (Day 1) to Final Visit (up to Week 12)]

    12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.

17. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

    Blood pressure was measured after the subject had been sitting for at least 3 minutes.

18. Heart Rate: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

    Heart rate was measured after the subject had been sitting for at least 3 minutes.

19. Oral Body Temperature: Mean Change From Baseline to Final Visit [Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)]

20. Number of Subjects With Potentially Clinically Significant Physical Examination Findings [Baseline (Day 1) and Final Visit (up to Week 12)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening

• Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism

• For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:

• A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL

• A phosphorus value ≤ 6.5 mg/dL

• An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

Exclusion Criteria:

• Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy

• Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)

• Subject has had a parathyroidectomy within 12 weeks prior to Screening

• Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening

• Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing

• Subject is receiving cinacalcet at the time of Screening

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Ann Eldred, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Prescribing Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01382212
• Other Study ID Numbers: M11-612; 2013-002610-13
• First Posted: Jun 27, 2011
• Last Update Posted: Jul 2, 2018
• Last Verified: Nov 1, 2016

• Keywords provided by AbbVie (prior sponsor, Abbott): Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

Participant Flow

Pre-assignment Detail	A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Period Title: Overall Study
STARTED	13
COMPLETED	11
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Participants	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.5 (1.76)
Sex: Female, Male (Count of Participants)
Female	8 61.5%
Male	5 38.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Hypercalcemia
Description	The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).
Time Frame	Day 1 to Week 12

Outcome Measure Data

Analysis Population Description

All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Number (95% Confidence Interval) [percentage of participants]	15.3 117.7%

2. Secondary Outcome

Title	Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
Time Frame	Baseline (last measurement collected prior to the first dose) to Week 12

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Number (95% Confidence Interval) [percentage of participants]	38.5 296.2%

3. Secondary Outcome

Title	Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
Time Frame	Baseline (last measurement collected prior to the first dose) to Week 12

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Number (95% Confidence Interval) [percentage of participants]	61.5 473.1%

4. Secondary Outcome

Title	Hemoglobin: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Mean (Standard Deviation) [g/dL]	-0.1 (1.263)

5. Secondary Outcome

Title	Hematocrit: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Mean (Standard Deviation) [percent]	-1.08 (5.066)

6. Secondary Outcome

Title	Red Blood Cells: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Mean (Standard Deviation) [cells x 10^6/µL]	-0.09 (0.496)

7. Secondary Outcome

Title	White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
WBC	-0.06 (2.982)
Platelet Count	19.2 (47.03)

8. Secondary Outcome

Title	Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Neutrophils	0.11 (2.6812)
Lymphocytes	-0.294 (0.597)
Monocytes	0.032 (0.1276)
Eosinophils	0.059 (0.1522)
Basophils	-0.01 (0.0322)

9. Secondary Outcome

Title	Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
Description	n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
ALT (n=11)	-4.55 (16.501)
AST (n=11)	-4.45 (12.25)
LDH (n=11)	-6.5 (33.22)
BSAP (n=9)	-49.4 (86.95)

10. Secondary Outcome

Title	Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit
Description	n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Total bilirubin (n=11)	0.032 (0.3165)
Direct Bilirubin (n=11)	0.013 (0.0785)
Indirect Bilirubin (n=9)	0.056 (0.3035)
BUN (n=11)	1.33 (11.614)
Uric Acid (n=11)	0.31 (1.245)
Magnesium (n=11)	0.082 (0.3649)
Glucose (n=11)	4.36 (10.172)
Cholesterol (n=11)	-16.4 (27.37)
Triglycerides (n=11)	9.2 (40.32)
hsCRP (n=11)	0.061 (0.1967)
Inorganic phosphate (n=13)	0.64 (1.188)
Corrected Calcium (n=7)	0.31 (0.421)
Creatinine (n=11)	0.48 (1.592)

11. Secondary Outcome

Title	Alkaline Phosphatase: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Mean (Standard Deviation) [IU/L]	-61.8 (117.34)

12. Secondary Outcome

Title	Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	11
Sodium	-0.5 (2.02)
Potassium	0.25 (0.746)
Chloride	0.5 (3.21)
Bicarbonate	-0.45 (3.446)

13. Secondary Outcome

Title	Total Protein and Albumin: Mean Change From Baseline to Final Visit
Description	n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Total protein (n=11)	0.15 (0.43)
Albumin (n=13)	0.04 (0.325)

14. Secondary Outcome

Title	Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit
Description	n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
FGF-23 (n=10)	1990.7 (3317.7)
1,25-Hydroxy Vitamin D (n=11)	15.65 (29.296)
25-Hydroxy Vitamin D (n=11)	5.8 (10.38)
iPTH (n=13)	-437.5 (491.83)

15. Secondary Outcome

Title	Osteocalcin: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	10
Mean (Standard Deviation) [ng/mL]	117.21 (223.07)

16. Secondary Outcome

Title	Number of Subjects With Adverse Events
Description	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time Frame	From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Any TEAE	11 84.6%
TESAE	2 15.4%

17. Secondary Outcome

Title	Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Description	12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.
Time Frame	Baseline (Day 1) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Number [participants]	0 0%

18. Secondary Outcome

Title	Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
Description	Blood pressure was measured after the subject had been sitting for at least 3 minutes.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
SBP	7.5 (15.66)
DBP	3.7 (12.98)

19. Secondary Outcome

Title	Heart Rate: Mean Change From Baseline to Final Visit
Description	Heart rate was measured after the subject had been sitting for at least 3 minutes.
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Mean (Standard Deviation) [bpm]	1.8 (17.43)

20. Secondary Outcome

Title	Oral Body Temperature: Mean Change From Baseline to Final Visit
Time Frame	Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Mean (Standard Deviation) [degrees Celsius]	0.03 (0.338)

21. Secondary Outcome

Title	Number of Subjects With Potentially Clinically Significant Physical Examination Findings
Time Frame	Baseline (Day 1) and Final Visit (up to Week 12)

Outcome Measure Data

Analysis Population Description

All-treated data set

Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Measure Participants	13
Number [participants]	0 0%

Adverse Events

Time Frame	Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Arm/Group Title	Paricalcitol
Arm/Group Description	Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
All Cause Mortality
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	2/13 (15.4%)
Injury, poisoning and procedural complications
PERITONEAL DIALYSIS COMPLICATION	1/13 (7.7%)
Metabolism and nutrition disorders
FLUID OVERLOAD	1/13 (7.7%)
Other (Not Including Serious) Adverse Events
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	10/13 (76.9%)
Gastrointestinal disorders
ABDOMINAL PAIN	1/13 (7.7%)
ABDOMINAL PAIN UPPER	1/13 (7.7%)
DIARRHOEA	1/13 (7.7%)
NAUSEA	2/13 (15.4%)
VOMITING	1/13 (7.7%)
General disorders
INFLUENZA LIKE ILLNESS	1/13 (7.7%)
PYREXIA	2/13 (15.4%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	1/13 (7.7%)
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE COMPLICATION	1/13 (7.7%)
PROCEDURAL PAIN	1/13 (7.7%)
PROCEDURAL VOMITING	1/13 (7.7%)
Investigations
BLOOD CALCIUM INCREASED	1/13 (7.7%)
HAEMOGLOBIN DECREASED	1/13 (7.7%)
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA	1/13 (7.7%)
Musculoskeletal and connective tissue disorders
BACK PAIN	1/13 (7.7%)
PAIN IN EXTREMITY	1/13 (7.7%)
Nervous system disorders
HEADACHE	1/13 (7.7%)
Respiratory, thoracic and mediastinal disorders
COUGH	2/13 (15.4%)
THROAT IRRITATION	1/13 (7.7%)
Skin and subcutaneous tissue disorders
PRURITUS	1/13 (7.7%)
Vascular disorders
HYPERTENSION	1/13 (7.7%)

Limitations/Caveats

The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.