A Controlled Study of Uric Acid on the Progression of IgA Nephropathy

Study Overview
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Brief Summary
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This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.

Detailed Description
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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.

Official Title
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A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: allopurinol
* Other: continue their usual therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old. Biopsy-proven IgA nephropathy. Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level>3.5g/dl. Serum creatinine < 3 mg/dl. Uric acid > 6 mg//dl (360umol/dl) in female; Uric acid >7mg/dl (420umol/dl ) in male. No history of taking ACEI or ARB within 2 weeks. Blood pressure < 180/110 mmHg. Subjects who agree to participate in the study and sign the informed consent. Exclusion Criteria: Patients who have received prednisone or immunosuppressive drugs within 2 months. Patients who must take ACEI or ARB due to other diseases. Patients who have the history of allergy to allopurinol. Unwillingness to follow the study protocol. Active gout within 4 weeks. Pregnancy or unwillingness to use contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allopurinol<br>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. | Drug: allopurinol<br>* 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.<br>|
| Other: Control group<br>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<br>* Patients will receive lifestyle modification and continue their usual therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Renal Function as Measured With eGFR |  | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). |  | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgA nephropathy