Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Atrial fibrillation (AF) is fairly prevalent in patients with end stage renal disease (ESRD) with the prevalence estimated to be 3.8 - 27%. While it is reported that patient with peritoneal dialysis (PD) has a lower incidence of AF as compared to patient with haemodialysis (HD), the risk is still substantially higher than in the general population. AF is a known risk factor for embolic stroke and stroke causes significant morbidity and mortality. Anticoagulation in an effective treatment for the prevention of stroke in the general population. However, this is less clear in the ESRD populations. Despite the risk of stroke is higher than general population, the management of AF in patients with ESRD remains controversial with limited and often conflicting result for the use of traditional vitamin K antagonists. It also showed an increased risk of bleeding with the use in ESRD patients. With the advent of direct oral anticoagulants (DOACs), there is growing interest in advocating their uses and studies have been done to assess their safety profile. In fact, several randomized control trials are being performed. However, these studies are done in HD populations and there is no data for PD populations at all so far. Given the physiology of drug clearance is different between the two renal replacement modalities, the investigators purpose to assess the pharmacokinetics and the safety profile of Apixaban in PD populations. By establishing the pharmacokinetics and its safety profile, apixaban may be a more attractive option for anticoagulation for AF or other venous thrombotic indications in PD population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• stable PD patients with non-valvular AF and with no significant residual renal function

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Medicine & Therapeutics, Prince of Wales Hospital
RECRUITING
Shatin
Contact Information
Primary
Winston WS Fung, MBBS
fws898@ha.org.hk
852-55699689
Backup
Cheuk Chun C Szeto, MD
ccszeto@cuhk.edu.hk
852-35053146
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 50
Treatments
Study group
stable PD patients with non-valvular AF
Sponsors
Collaborators: Prince of Wales Hospital, Shatin, Hong Kong
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov