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

Sun Yat-sen University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgA Nephropathy

Interventions

allopurinolDRUG

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.

continue their usual therapyOTHER

Patients will receive lifestyle modification and continue their usual therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old. 2. Biopsy-proven IgA nephropathy. 3. Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level\>3.5g/dl. 4. Serum creatinine \< 3 mg/dl. 5. Uric acid \> 6 mg//dl (360umol/dl) in female; Uric acid \>7mg/dl (420umol/dl ) in male. 6. No history of taking ACEI or ARB within 2 weeks. 7. Blood pressure \< 180/110 mmHg. 8. Subjects who agree to participate in the study and sign the informed consent. Exclusion Criteria: 1. Patients who have received prednisone or immunosuppressive drugs within 2 months. 2. Patients who must take ACEI or ARB due to other diseases. 3. Patients who have the history of allergy to allopurinol. 4. Unwillingness to follow the study protocol. 5. Active gout within 4 weeks. 6. Pregnancy or unwillingness to use contraception.

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change in Renal Function as Measured With eGFR

Time frame: baseline and 6 months

Secondary Outcomes

The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).

Time frame: baseline and 6 months

Data from ClinicalTrials.gov

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