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Apixaban in Subjects With Peritoneal Dialysis (ApiDP)

Primary Purpose

Chronic Renal Insufficiency, Peritoneal Dialysis

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Apixaban Oral
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Renal Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

participants with normal renal function

participants with end-stage renal disease

Arm Description

Outcomes

Primary Outcome Measures

Apixaban area Under the curve
Measurement of apixaban plasma concentrations at different times.
Apixaban maximum plasma concentration
Measurement of apixaban plasma concentrations at different times.

Secondary Outcome Measures

anti-Xa activity
anti-Xa activity plasma measurements
TP activity
TP activity plasma measurements
TCA activity
TCA activity plasma measurements
Apixaban urinary elimination
Measurement of apixaban urinary concentrations
Apixaban maximum peritoneal concentration
Measurement of apixaban peritoneal fluid concentrations

Full Information

First Posted
June 5, 2019
Last Updated
January 18, 2023
Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04006093
Brief Title
Apixaban in Subjects With Peritoneal Dialysis
Acronym
ApiDP
Official Title
Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 8, 2019 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Peritoneal Dialysis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participants with normal renal function
Arm Type
Experimental
Arm Title
participants with end-stage renal disease
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apixaban Oral
Intervention Description
one Tablet 5mg
Primary Outcome Measure Information:
Title
Apixaban area Under the curve
Description
Measurement of apixaban plasma concentrations at different times.
Time Frame
Day 3
Title
Apixaban maximum plasma concentration
Description
Measurement of apixaban plasma concentrations at different times.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
anti-Xa activity
Description
anti-Xa activity plasma measurements
Time Frame
Hour 0, Hour 3, Hour 9 and Hour 72
Title
TP activity
Description
TP activity plasma measurements
Time Frame
Hour 0, Hour 3, Hour 9 and Hour 72
Title
TCA activity
Description
TCA activity plasma measurements
Time Frame
Hour 0, Hour 3, Hour 9 and Hour 72
Title
Apixaban urinary elimination
Description
Measurement of apixaban urinary concentrations
Time Frame
Day 3
Title
Apixaban maximum peritoneal concentration
Description
Measurement of apixaban peritoneal fluid concentrations
Time Frame
day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Apixaban in Subjects With Peritoneal Dialysis

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