Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Hyperuricemia; Abnormal Renal Function
• Interventions: Drug: Febuxostat; Drug: Benzbromarone

• Registration Number: NCT02338323
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-10
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat	Febuxostat	take orally, 40mg per day, for 1 year
Benzbromarone	Benzbromarone	take orally, 50mg per day, for 1 year

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China