Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02338323

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Hyperuricemia Abnormal Renal Function	Drug: Febuxostat Drug: Benzbromarone	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Febuxostat

take orally, 40mg per day, for 1 year

Drug: Febuxostat

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

Other Names:

Uloric

Adenuric

Experimental: Benzbromarone

take orally, 50mg per day, for 1 year

Drug: Benzbromarone

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

Other Names:

Desuric

Outcome Measures

Primary Outcome Measures

Renal function [up to 12th months]
Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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