Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Overview

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

Full Title of Study: “Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2018

Detailed Description

Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-50 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.

Interventions

  • Drug: Febuxostat
    • It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
  • Drug: Benzbromarone
    • It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase

Arms, Groups and Cohorts

  • Experimental: Febuxostat
    • take orally, 40mg per day, for 1 year
  • Experimental: Benzbromarone
    • take orally, 50mg per day, for 1 year

Clinical Trial Outcome Measures

Primary Measures

  • Renal function
    • Time Frame: up to 12th months
    • Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate

Secondary Measures

  • urine protein
    • Time Frame: 3rd months, 6th months, 9th months, 12th months
    • urine test for microprotein markers and 24-hour urine protein quantitation
  • adverse drug reaction
    • Time Frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
    • record all the adverse drug reactions

Participating in This Clinical Trial

Inclusion Criteria

Chronic kidney disease patients with glomerular filtration rate (GFR,20-50ml/min) who match one of the following criteria:

1. Gout

2. Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid > 480umol/L

3. Hyperuricemia patients without gout but with serum uric acid > 540umol/L

Exclusion Criteria

1. GFR<20ml/min or GFR >50ml/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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai 10th People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ai Peng, Chief of department of Nephrology & Rheumatology – Shanghai 10th People’s Hospital
  • Overall Official(s)
    • Ling Wang, MD, PhD, Study Chair, Department of Nephrology & Rheumatology, Shanghai Tenth People’s Hospital

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