Clinical trial NCT05532878: Pharmacokinetics of Apixaban in Peritoneal Dialysis
Official title: Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: peritoneal dialysis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2022-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stable PD patients with non-valvular AF and with no significant residual renal function

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Apixabn level
timeFrame: 0 to 12 hours (14 time points)
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: Winston WS Fung, MBBS
role: PRINCIPAL_INVESTIGATOR
References: