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Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients (LUMINA)

Primary Purpose

Hyperuricemia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Febuxostat

Placebo

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Continuous Ambulatory Peritoneal Dialysis (CAPD), Hyperuricemia, Cardiovascular events, Treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) <serum uric acid (sUA)<12mg/dl(720μmol/L); men: 7mg/dl(420μmol/L)<sUA<12mg/dl(720μmol/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

Sites / Locations

The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with Febuxostat

Treatment with placebo

Arm Description

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

Same dose and dose adjustment as the intervention arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause mortality

To record and calculate the deaths caused by any cause during follow up period

Cardiovascular mortality

To record and calculate the deaths cardiovascular mortality includes acute myocardial infarction, fatal arrhythmia, sudden death, cardiomyopathy, heart failure, and stroke during follow up period.

Non-fatal cardiovascular events

To record and calculate the non-fatal cardiovascular events including 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 during follow up period.

Full Information

NCT ID

NCT03200210

First Posted

June 25, 2017

Last Updated

October 20, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03200210

Brief Title

Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

Acronym

LUMINA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Febuxostat

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment with placebo

Arm Type

Placebo Comparator

Arm Description

Same dose and dose adjustment as the intervention arm.

Intervention Type

Drug

Intervention Name(s)

Febuxostat

Other Intervention Name(s)

Febuxostat Tablets

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pills manufactured to mimic Febuxostat tablets

Primary Outcome Measure Information:

Title

Cardiovascular events

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

All-cause mortality

Description

To record and calculate the deaths caused by any cause during follow up period

Time Frame

3 years

Title

Cardiovascular mortality

Description

To record and calculate the deaths cardiovascular mortality includes acute myocardial infarction, fatal arrhythmia, sudden death, cardiomyopathy, heart failure, and stroke during follow up period.

Time Frame

3 years

Title

Non-fatal cardiovascular events

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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) <serum uric acid (sUA)<12mg/dl(720μmol/L); men: 7mg/dl(420μmol/L)<sUA<12mg/dl(720μmol/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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xueqing Yu, MD, PhD

Phone

8620-87766335

yuxq@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, MD, PhD

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, M.D. & Ph.D

Phone

8620-8776633

yuxq@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, M.D. & Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33040002

Citation

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.

Results Reference

derived

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Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

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