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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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.

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,10-80mg per day, for 1 year,start with a low dose, and adjust the dose according to the level of uric acid
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 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, Professor – Shanghai 10th People’s Hospital
  • Overall Official(s)
    • Ai Peng, MD, PhD, Study Chair, Department of Nephrology & Rheumatology, Shanghai Tenth People’s Hospital
  • Overall Contact(s)
    • Ai Peng, MD,PhD, pengai@hotmail.com

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