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
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function in chinese, and which one could be better.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | 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 |
Status | Clinical Trial | Phase | |
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