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

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 in chinese, and which one could be better.

Detailed Description
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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.

Official Title
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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

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,20-60ml/min) who match one of the following criteria: Gout serum uric acid > 480umol/L Exclusion Criteria: GFR<20ml/min or GFR >60ml/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: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Febuxostat<br>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<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,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<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 |
| --- | --- | --- |
| serum creatinine, estimated glomerular filtration rate (eGFR) | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| urine protein |  | 6th months, 12th months | 
| adverse drug reaction |  | 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