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ApiDP: Apixaban in Subjects With Peritoneal Dialysis

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT04006093
Collaborator
University Hospital, Rouen (Other)
24
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.

Condition or Disease Intervention/Treatment Phase
  • Drug: Apixaban Oral
 Phase 1

Detailed Description

Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: participants with normal renal function

Drug: Apixaban Oral
one Tablet 5mg
Experimental: participants with end-stage renal disease

Drug: Apixaban Oral
one Tablet 5mg

Outcome Measures

Primary Outcome Measures

  1. Apixaban area Under the curve [Day 3]

    Measurement of apixaban plasma concentrations at different times.

  2. Apixaban maximum plasma concentration [Day 3]

    Measurement of apixaban plasma concentrations at different times.

Secondary Outcome Measures

  1. anti-Xa activity [Hour 0, Hour 3, Hour 9 and Hour 72]

    anti-Xa activity plasma measurements

  2. TP activity [Hour 0, Hour 3, Hour 9 and Hour 72]

    TP activity plasma measurements

  3. TCA activity [Hour 0, Hour 3, Hour 9 and Hour 72]

    TCA activity plasma measurements

  4. Apixaban urinary elimination [Day 3]

    Measurement of apixaban urinary concentrations

  5. Apixaban maximum peritoneal concentration [day 3]

    Measurement of apixaban peritoneal fluid concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Participant with 21<BMI<40

  • French participant

  • Participant able to consent

  • Participant with social insurance

  • Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated

Exclusion Criteria:

  • Participant with hypersensibility reactions to apixaban

  • Participant with a history of major bleeding

  • Participant already on anticoagulant

  • Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage > 300 mg

  • Participant on potent inhibitors of CYP 3A4 and P-gp

  • Participant on inducers of CYP3A4 and P-sp

  • Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

  • Participant receiving or having received antibiotic treatment within 14 days prior to study

  • Pregnant or lactating women

  • Participant with known hypersensitivity reactions to icodextrin

  • Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)

  • Participant with "Normal renal function" with glomerular filtration rate < 90 ml/min

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Caen
  • University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT04006093
Other Study ID Numbers:
  • 19-060
First Posted:
Jul 2, 2019
Last Update Posted:
Jul 10, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Apixaban

Study Results

No Results Posted as of Jul 10, 2019