Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

NCT03200210 | Unknown Phase 4 DMC

• 1 other identifier: LUMINA
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperuricemia

Keywords

Continuous Ambulatory Peritoneal Dialysis (CAPD); Hyperuricemia; Cardiovascular events; Treatment

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Cardiovascular events compose of cardiovascular mortality and non-fatal cardiovascular events, cardiovascular mortality includes acute myocardial infarction, fatal arrhythmia, sudden death, cardiomyopathy, heart failure, and stroke; non-fatal cardiovascular events includes non-fatal acute myocardial infarction, hospital admission of heart failure, unstable angina, atherosclerotic disease needed hospitalization (including aneurysm, arterial dissection, arteriosclerosis occlusion), non-fatal stroke, transient ischaemic attack or lower limb ischaemia

  3 years

Secondary Outcomes (3)

• All-cause mortality

  3 years

• Cardiovascular mortality

  3 years

• Non-fatal cardiovascular events

  3 years

Study Arms (2)

Treatment with Febuxostat

EXPERIMENTAL

Febuxostat, starting at dose 20mg/d, once a day. And adjust dose according to serum uric acid at specific visits.

Drug: Febuxostat

Treatment with placebo

PLACEBO COMPARATOR

Same dose and dose adjustment as the intervention arm.

Drug: Placebo

Interventions

Febuxostat DRUG

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.

Also known as: Febuxostat Tablets

Treatment with Febuxostat

Placebo DRUG

Pills manufactured to mimic Febuxostat tablets

Treatment with placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to understand and have voluntarily signed the informed consent form (ICF)
• years old at the time of randomization
• Subjects on PD for more than 3 months.
• Subjects have hyperuricemia, women: 6mg/dl(360μmol/L) \<serum uric acid (sUA)\<12mg/dl(720μmol/L); men: 7mg/dl(420μmol/L)\<sUA\<12mg/dl(720μmol/L).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• Chen W, Huang N, Mao H, Yang X, Zhou Q, Jiang L, Ding J, Feng Q, Yu X. Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA). BMJ Open. 2020 Oct 10;10(10):e037842. doi: 10.1136/bmjopen-2020-037842.

  PMID: 33040002 DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xueqing Yu, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqing Yu, MD, PhD

CONTACT

8620-87766335; yuxq@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: June 27, 2017
• Study Start: July 11, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)