Pharmacokinetics of Apixaban in Peritoneal Dialysis

Atrial Fibrillation Clinical Trial

Official title:

Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532878
• Other study ID #: CRE-2020.284
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Winston WS Fung, MBBS
• Phone: 852-55699689
• Email: fws898[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• increased risk of bleeding and those with contraindications to anticoagulation such as history of gastrointestinal bleeding, dual anti-platelet therapy, active malignancy, recent trauma and stroke

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Apixaban 2.5 mg daily

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apixabn level	Blood anti-factor Xa activity	0 to 12 hours (14 time points)