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

April 25, 2016 updated by: Xue Qing Yu, Sun Yat-sen University

A Prospective, Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510080
        • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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: Control group
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
Patients will receive lifestyle modification and continue their usual therapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (ESTIMATE)

November 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGIgAN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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