Skip to main content
OpenTrials
Completed

NCT Number: NCT00793585

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allopurinol

Drug

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 therapy

Other

Patients will receive lifestyle modification and continue their usual therapy.

Primary outcomes

  1. Change in Renal Function as Measured With eGFR

    Time frame: baseline and 6 months

Secondary outcomes

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

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.