Pharmacokinetics of Apixaban in Peritoneal Dialysis

NCT05532878 | Recruiting

• 1 other identifier: CRE-2020.284
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Apixabn level

  Blood anti-factor Xa activity

  0 to 12 hours (14 time points)

Study Arms (1)

Study group

stable PD patients with non-valvular AF

Drug: Apixaban

Interventions

Apixaban DRUG

Apixaban 2.5 mg daily

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Winston WS Fung, MBBS

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winston WS Fung, MBBS

CONTACT

852-55699689; fws898@ha.org.hk

Cheuk Chun C Szeto, MD

CONTACT

852-35053146; ccszeto@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine & Therapeutics

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)