Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Shanghai 10th People's Hospital160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Chronic Kidney Disease Hyperuricemia Abnormal Renal Function

Interventions

FebuxostatDRUG

It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body

BenzbromaroneDRUG

It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Renal function

Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate

Time frame: up to 12th months

Secondary Outcomes

urine protein

urine test for microprotein markers and 24-hour urine protein quantitation

Time frame: 3rd months, 6th months, 9th months, 12th months

adverse drug reaction

record all the adverse drug reactions

Time frame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.