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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02338323
Other study ID # FB2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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