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

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ClinicalTrials.gov Identifier: NCT03200210
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: Febuxostat Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients: A Prospective, Multicenter, Double-Blinded, Randomized Controlled Trial
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Febuxostat

Arm Intervention/treatment
Experimental: Treatment with Febuxostat
Febuxostat, starting at dose 20mg/d, once a day. And adjust dose according to serum uric acid at specific visits.
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.
Other Name: Febuxostat Tablets

Placebo Comparator: Treatment with placebo
Same dose and dose adjustment as the intervention arm.
Drug: Placebo
Pills manufactured to mimic Febuxostat tablets




Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 3 years ]
    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 :
  1. All-cause mortality [ Time Frame: 3 years ]
    To record and calculate the deaths caused by any cause during follow up period

  2. Cardiovascular mortality [ Time Frame: 3 years ]
    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.

  3. Non-fatal cardiovascular events [ Time Frame: 3 years ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200210


Contacts
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Contact: Xueqing Yu, MD, PhD 8620-87766335 yuxq@mail.sysu.edu.cn

Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xueqing Yu, M.D. & Ph.D    8620-8776633    yuxq@mail.sysu.edu.cn   
Contact: Yu         
Principal Investigator: Xueqing Yu, M.D. & Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xueqing Yu, MD, PhD First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03200210     History of Changes
Other Study ID Numbers: LUMINA
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xue Qing Yu, Sun Yat-sen University:
Continuous Ambulatory Peritoneal Dialysis (CAPD)
Hyperuricemia
Cardiovascular events
Treatment

Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Febuxostat
Gout Suppressants
Antirheumatic Agents