Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    548
  • sponsor
    Sun Yat-sen University
Updated on 26 January 2021
Uric Acid Test
serum uric acid
febuxostat

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.

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.

Details
Condition Hyperuricemia
Treatment Placebo, Febuxostat
Clinical Study IdentifierNCT03200210
SponsorSun Yat-sen University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Hyperuricemia?
Do you have any of these conditions: Do you have Hyperuricemia??
Subjects who are able to understand and have voluntarily signed the informed consent form (ICF)
-70 years old at the time of randomization
Subjects on PD for more than 3 months
Subjects have hyperuricemia, women: 6mg/dl(360mol/L) <serum uric acid (sUA)<12mg/dl(720mol/L); men: 7mg/dl(420mol/L)<sUA<12mg/dl(720mol/L)

Exclusion Criteria

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 of4 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
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