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Completed

NCT Number: NCT04006093

Apixaban in Subjects With Peritoneal Dialysis

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.

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Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Dialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Caen

Caen, 14000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban single dose 5mg

Drug

Apixaban oral single dose 5mg

Primary outcomes

  1. Apixaban area Under the curve

    Time frame: Day 3

    Measurement of apixaban plasma concentrations at different times.

  2. Apixaban maximum plasma concentration

    Time frame: Day 3

    Measurement of apixaban plasma concentrations at different times.

Secondary outcomes

  1. anti-Xa activity

    Time frame: Hour 0, Hour 3, Hour 9 and Hour 72

    anti-Xa activity plasma measurements

  2. TP activity

    Time frame: Hour 0, Hour 3, Hour 9 and Hour 72

    TP activity plasma measurements

  3. TCA activity

    Time frame: Hour 0, Hour 3, Hour 9 and Hour 72

    TCA activity plasma measurements

  4. Apixaban urinary elimination

    Time frame: Day 3

    Measurement of apixaban urinary concentrations

  5. Apixaban maximum peritoneal concentration

    Time frame: day 3

    Measurement of apixaban peritoneal fluid concentrations

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: ApiDP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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