Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05532878

Pharmacokinetics of Apixaban in Peritoneal Dialysis

Led by Chinese University of Hong Kong · Updated on 2024-06-25

50

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

Sponsors

C

Chinese University of Hong Kong

Lead Sponsor

P

Prince of Wales Hospital, Shatin, Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Pharmacokinetics of Apixaban in Peritoneal Dialysis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stable peritoneal dialysis patients with non-valvular atrial fibrillation
  • No significant residual kidney function
Not Eligible

You will not qualify if you...

  • Increased risk of bleeding
  • History of gastrointestinal bleeding
  • Use of dual anti-platelet therapy
  • Active cancer
  • Recent trauma
  • Recent stroke

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Trial Site Locations

Total: 1 location

1

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Actively Recruiting

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Research Team

W

Winston WS Fung, MBBS

CONTACT

C

Cheuk Chun C Szeto, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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