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
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 |
Verified date | July 2019 |
Source | Shanghai 10th People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better.
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
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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