Compare the Renal Protective Effects of Febuxostat and Benzbromarone

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

Detailed Description
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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.

Official Title
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Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min

Conditions
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Chronic Kidney Disease, Hyperuricemia, Abnormal Renal Function

Intervention / Treatment
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* Drug: Febuxostat
* Drug: Benzbromarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease patients with glomerular filtration rate (GFR,20-50ml/min) who match one of the following criteria: Gout Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid > 480umol/L Hyperuricemia patients without gout but with serum uric acid > 540umol/L Exclusion Criteria: GFR<20ml/min or GFR >50ml/min Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range) Urinary tract obstruction unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment Severe lung diseases or cancers Pregnant woman or woman who prepare to be pregnant，nursing mothers unable to sign informed consent form，or disagree with following-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Febuxostat<br>take orally, 40mg per day, for 1 year | Drug: Febuxostat<br>* It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body<br>* Other names: Adenuric;|
| Experimental: Benzbromarone<br>take orally, 50mg per day, for 1 year | Drug: Benzbromarone<br>* It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase<br>* Other names: Desuric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate | up to 12th months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone