NCT03200210

Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients: A Prospective, Multicenter, Double-Blinded, Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 548 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The investigators will enroll continuous ambulatory peritoneal dialysis (CAPD) patients with hyperuricemia and randomly divide them into two groups, treated with Febuxostat and placebo respectively. After 3 years of following up, cardiovascular events, all cause mortality, cardiovascular mortality and non-fatal cardiovascular events are collected and recorded. The difference of cardiovascular events, all cause mortality and non-fatal cardiovascular event rate will be analyzed.

Detailed description

The investigators anticipate enrolling 548 CAPD patients who have hyperuricemia in 21 centers and randomly allocate them into Febuxostat treatment group and placebo group. This study is double-blinded and will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are all-cause mortality, cardiovascular mortality and non-fatal cardiovascular events separately. All the endpoints will be collected, as well as other outcomes, such as blood pressure and dialysis dose and so on. The outcomes will be analyzed using statistics software.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Febuxostat	Febuxostat tablets would be given to patients at dose of 20mg/d, once a day, and dose would be adjusted according to serum uric acid at specific visits.
DRUG	Placebo	Pills manufactured to mimic Febuxostat tablets

Timeline

• Start date: 2017-07-11
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-06-27
• Last updated: 2020-10-22

Locations

1 site across 1 country: China