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

Not Applicable

Completed

• Conditions: IgA Nephropathy
• Interventions: Other: continue their usual therapy; Drug: allopurinol

• Registration Number: NCT00793585
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2009-10-28
• Results First Submitted QC: 2011-06-06
• Results First Posted: 2011-07-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	continue their usual therapy	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.
Allopurinol	allopurinol	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.

Primary Outcome Measures

Name	Time	Method
Change in Renal Function as Measured With eGFR	baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).	baseline and 6 months

Trial Locations

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University; 🇨🇳 GuangZhou, Guangdong, China