Apixaban in Subjects With Peritoneal Dialysis

Peritoneal Dialysis Clinical Trial

— ApiDP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006093
• Other study ID #: 19-060
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2019
• Est. completion date: December 10, 2022

Study information

• Verified date: April 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Peritoneal Dialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Apixaban Oral
one Tablet 5mg

Locations

Country	Name	City	State
France	CHU Caen	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apixaban area Under the curve	Measurement of apixaban plasma concentrations at different times.	Day 3
Primary	Apixaban maximum plasma concentration	Measurement of apixaban plasma concentrations at different times.	Day 3
Secondary	anti-Xa activity	anti-Xa activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
Secondary	TP activity	TP activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
Secondary	TCA activity	TCA activity plasma measurements	Hour 0, Hour 3, Hour 9 and Hour 72
Secondary	Apixaban urinary elimination	Measurement of apixaban urinary concentrations	Day 3
Secondary	Apixaban maximum peritoneal concentration	Measurement of apixaban peritoneal fluid concentrations	day 3