Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Febuxostat

Criteria

Inclusion Criteria:

• 1.Subjects who are able to understand and have voluntarily signed the informed consent form (ICF)

• 18-70 years old at the time of randomization

• Subjects on PD for more than 3 months.

• Subjects have hyperuricemia, women: 6mg/dl(360μmol/L)(sUA)<12mg/dl(720μmol/L); men: 7mg/dl(420μmol/L)

Exclusion Criteria:

• 1.Subjects has history of gout

• Subjects who have a myocardial infarction, unstable angina,cardiovascular reconstructive surgery (such as a stent or bypass surgery), cerebrovascular accident 12 weeks prior to randomization, or plan cardiovascular reconstructive surgery during the trial

• Subjects who have New York stage IV heart failure occurs 4 weeks prior to the screening

• Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy

• Subjects who have severe liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis

• Subjects who have alanine aminotransferase (ALT) greater than 2 folds of the upper limited of normal or total bilirubin greater than 1.5 folds of upper limited of normal

• Subjects who have severe infections 4 weeks prior to the screening, such as pneumonia and peritoneal dialysis-related peritonitis;

• Subjects who have a major surgery 12 weeks prior to screening or not yet fully recovered from the surgery

• Subjects who have a malignancy

• Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of≥4 alcoholic drinks per day in the 2 years before Screening

• Subjects who are allergic to Febuxostat

• Subjects who are enrolled in other clinical studies within 4 weeks or currently at randomization

• Subjects who are currently taking mercaptopurine, azathioprine, vidarabine, didanosine

• Subjects who are taking losartan, fenofibrate, thiazide diuretics or loop diuretics within 4 weeks at randomization

• Subjects who require long-term use of steroids (prednisone <30mg / d, or equivalent amount of other steroids and the use of <2 weeks can be enrolled)

• Subjects who require long-term use of salicylic acid drugs except low-dose aspirin

• Fertility, lactation patients unwilling or unable to contraception