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

Chronic Kidney Disease Clinical Trial

Official title:

Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Middle-to-late Stages of Chronic Kidney Disease Patients: a Multi-center Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02944214
• Other study ID #: FB2016MC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: October 24, 2016
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Shanghai 10th People's Hospital
• Contact: Ai Peng, MD,PhD
• Email: pengai[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Renal Function
• Chronic Kidney Disease
• Hyperuricemia
• Kidney Diseases
• Renal Insufficiency
• 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	serum creatinine, estimated glomerular filtration rate (eGFR)	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.	up to 12th months	No
Secondary	urine protein		6th months, 12th months	No
Secondary	adverse drug reaction		1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months	No