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

Tongji University

Status: Unknown

Conditions: Chronic Kidney Disease; Abnormal Renal Function; Hyperuricemia

Treatments: Drug: Benzbromarone; Drug: Febuxostat

Study type: Interventional

Funder types: Other

Identifiers

NCT02944214

FB2016MC

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Febuxostat

Experimental group

Description:

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

Treatment:

Drug: Febuxostat

Benzbromarone

Experimental group

Description:

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

Treatment:

Drug: Benzbromarone