Compare the Renal Protective Effects of Febuxostat and Benzbromarone

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338323
• Other study ID #: FB2015
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Renal Function
• Chronic Kidney Disease
• Hyperuricemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Febuxostat
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
• Benzbromarone
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase

Locations

Country	Name	City	State
China	Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate	up to 12th months
Secondary	urine protein	urine test for microprotein markers and 24-hour urine protein quantitation	3rd months, 6th months, 9th months, 12th months
Secondary	adverse drug reaction	record all the adverse drug reactions	1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months