Apixaban in Subjects With Peritoneal Dialysis (ApiDP)

Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis; Chronic Renal Insufficiency
• Intervention / Treatment: Drug: Apixaban single dose 5mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants in peritoneal dialysis; apixaban single dose 5mg in participants in peritoneal dialysis	Drug: Apixaban single dose 5mg; Apixaban oral single dose 5mg
Experimental: Participants with normal renal function; apixaban single dose 5mg in participants with normal renal function	Drug: Apixaban single dose 5mg; Apixaban oral single dose 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apixaban area Under the curve	Measurement of apixaban plasma concentrations at different times.	Day 3
Apixaban maximum plasma concentration	Measurement of apixaban plasma concentrations at different times.	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-Xa activity	anti-Xa activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
TP activity	TP activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
TCA activity	TCA activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
Apixaban urinary elimination	Measurement of apixaban urinary concentrations	Day 3
Apixaban maximum peritoneal concentration	Measurement of apixaban peritoneal fluid concentrations	day 3

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: University Hospital, Rouen

Publications and helpful links

General Publications

• Peyro-Saint-Paul L, Bechade C, Cesbron A, Debruyne D, Brionne M, Brucato S, Hanoy M, Dumont A, Briant AR, Parienti JJ, Lobbedez T, Ficheux M. Effect of peritoneal dialysis in end-stage renal disease on apixaban pharmacokinetics. Nephrol Dial Transplant. 2023 Jul 31;38(8):1918-1920. doi: 10.1093/ndt/gfad087. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2019
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; apixaban
• Other Study ID Numbers: 19-060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once the trial has finished and the main trial paper has been published, a fully anonymised trial data set will be available on reasonable request from Clinical Research Unit of University Hospital of Caen, Normandy, France
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No