Abnormal Renal Function, Chronic Kidney Disease, Hyperuricemia
Conditions
Keywords
Hyperuricemia, Renal Function, Chronic kidney disease, Febuxostat, Benzbromarone
Brief summary
The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better.
Detailed 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.
Interventions
DRUGFebuxostat
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
DRUGBenzbromarone
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | up to 12th months | Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urine protein | 3rd months, 6th months, 9th months, 12th months | urine test for microprotein markers and 24-hour urine protein quantitation |
| adverse drug reaction | 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months | record all the adverse drug reactions |
Countries
China
Outcome results
None listed