Effect of Hyperuricaemia on Chronic Renal Disease

February 6, 2018 updated by: The Affiliated Hospital of Xuzhou Medical University

Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aims to explore the best effective dose and adverse reaction of febuxostat in lowering serum uric acid to low level in patients with Chronic Renal Disease at different stages. To elucidate that low levels of serum uric acid can delay the progression of renal damage. Promote the application of anti uric acid drugs in the treatment of chronic renal failure and delay the progress of CKD in patients

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-dialysis CKD patients with serum uric acid greater than 7mg/dl.
  • eGFR≥15ml/min/1.73m².
  • Low salt, low protein, low purine diet.

Exclusion Criteria:

  • Take drugs that raise blood uric acid at the same time.
  • Patients with gout attacks.
  • Patients with pregnant, lactating.
  • Autosomal dominant polycystic kidney disease.
  • Patients with poor general condition and multiple organ failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group1
Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.
Drug: 20mg Febuxostat
Participants take 20mg febuxostat pill once a day for at least six months.
Other Names:
  • 20mg Febuxostat pill group
Active Comparator: Treatment group2
Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.
Drug: 40mg Febuxostat
Participants take 40mg febuxostat pill once a day for at least six months.
Other Names:
  • 40mg Febuxostat pill group
No Intervention: Control group
Treatment of CKD patients with hyperuricaemia with conventional methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum uric acid
Time Frame: up to 6 months
intravenous blood sampling
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: up to 6 months
intravenous blood sampling
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborators

The First People's Hospital of Xuzhou

Investigators

  • Study Director: Dong Sun, MD, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2017-KL043-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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