A Controlled Study of Uric Acid on the Progression of IgA Nephropathy
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy|
- Change in Renal Function as Measured With eGFR [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
- The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Allopurinol group:allopurinol, 100-300mg/d according to the levels of Scr(serum creatinine) and UA(uric acid), for those Scr < 1.5mg/dl (133 umol/L) at the baseline, allopurinol was given 100 mg three times daily.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level < 6mg/dl , the dosage changed to 200mg/d.
Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet and continue their usual therapy.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
Other: continue their usual therapy
Patients will receive lifestyle modification and continue their usual therapy.
It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793585
|The 1st Affiliated Hospital, Sun Yet-sen University|
|GuangZhou, Guangdong, China, 510080|
|Principal Investigator:||Xueqing Yu, M.D. & Ph.D.||1st Affiliated Hospital, Sun Yat-Sen University|