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HyperuricemiaPhase 4LUMINANCT03200210

Lowering-hyperuricemia Treatment on Cardiovascular Outcomes in Peritoneal Dialysis Patients

A Phase 4 study testing Febuxostat in people with Hyperuricemia, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hyperuricemia
What is being tested?
Febuxostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
548 participants
Where
1 siteChina
Study dates
11 Jul 2017to 31 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Xueqing Yu, MD, PhD contact

8620-87766335

yuxq@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Xueqing Yu, M.D. & Ph.D, 8620-8776633, yuxq@mail.sysu.edu.cn

    Yu

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Hyperuricemia
Being tested
Febuxostat, Placebo
Keywords
Continuous Ambulatory Peritoneal Dialysis (CAPD), Hyperuricemia, Cardiovascular events, Treatment
Medical subject headings
Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FebuxostatDrug

    Also called Febuxostat Tablets

    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.

  • PlaceboDrug

    Pills manufactured to mimic Febuxostat tablets

Study groups in NCT03200210
Study groupRoleWhat they receive
Treatment with FebuxostatExperimentalFebuxostat, starting at dose 20mg/d, once a day. And adjust dose according to serum uric acid at specific visits.
Receives: Drug: Febuxostat
Treatment with placeboPlacebo comparatorSame dose and dose adjustment as the intervention arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Secondary outcomes (3)

  1. All-cause mortality

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

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2017
  2. Study start11 Jul 2017
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
548 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03200210
Sponsor's protocol ID
LUMINA
Acronym
LUMINA
Status last verified
Oct 2020
First submitted
25 Jun 2017
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33040002

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Febuxostat in people with Hyperuricemia, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xueqing Yu, MD, PhD (8620-87766335, yuxq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular events (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03200210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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