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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793585
• Other study ID #: SYSU-PRGIgAN-002
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: May 19, 2015
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• allopurinol
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.

Other:
• continue their usual therapy
Patients will receive lifestyle modification and continue their usual therapy.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Renal Function as Measured With eGFR		baseline and 6 months	Yes
Secondary	The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).		baseline and 6 months	Yes