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

Not Applicable

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

• Registration Number: NCT02944214
• 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 in chinese, and which one could be better.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-24
• Last Update Submitted: 2016-10-24
• Study First Posted: 2016-10-25
• Last Update Posted: 2016-10-25
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Chronic kidney disease patients with glomerular filtration rate (GFR,20-60ml/min) who match one of the following criteria:

1. Gout
2. serum uric acid > 480umol/L

Exclusion Criteria

1. GFR<20ml/min or GFR >60ml/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
Benzbromarone	Benzbromarone	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
Febuxostat	Febuxostat	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

Primary Outcome Measures

Name	Time	Method
serum creatinine, estimated glomerular filtration rate (eGFR)	up to 12th months	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.

Secondary Outcome Measures

Name	Time	Method
urine protein	6th months, 12th months
adverse drug reaction	1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months

Trial Locations

Locations (1)

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