Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients

October 24, 2016 updated by: Ai Peng, Shanghai 10th People's Hospital

Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study

The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-60 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
        • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria:

  1. Gout
  2. serum uric acid > 480umol/L

Exclusion Criteria:

  1. GFR<20ml/min or GFR >60ml/min
  2. Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range)
  3. Urinary tract obstruction
  4. unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment
  5. Severe lung diseases or cancers
  6. Pregnant woman or woman who prepare to be pregnant，nursing mothers
  7. unable to sign informed consent form，or disagree with following-up

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Febuxostat
take orally,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid
Drug: Febuxostat
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
Other Names:
  • Uloric
  • Adenuric
Experimental: Benzbromarone
take orally,12.5-100mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid
Drug: Benzbromarone
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
Other Names:
  • Desuric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine, estimated glomerular filtration rate (eGFR)
Time Frame: up to 12th months
eGFR will be estimated by CKD-EPI equation, which is most widely used recently in the world. eGFR will be calculated according to serum creatinine, age, gender and race.
up to 12th months

Secondary Outcome Measures

Outcome Measure
Time Frame
urine protein
Time Frame: 6th months, 12th months
6th months, 12th months
adverse drug reaction
Time Frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months

Collaborators and Investigators

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

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Study Chair: Ai Peng, MD, PhD, Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

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

October 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FB2016MC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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