Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University Identifier:
First received: November 17, 2008
Last updated: April 25, 2016
Last verified: April 2016
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.

Condition Intervention
IgA Nephropathy
Drug: allopurinol
Other: continue their usual therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Change in Renal Function as Measured With eGFR [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures:
  • The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). [ Time Frame: baseline and 6 months ]

Enrollment: 40
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00793585

China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University Identifier: NCT00793585     History of Changes
Other Study ID Numbers: SYSU-PRGIgAN-002
Study First Received: November 17, 2008
Results First Received: October 28, 2009
Last Updated: April 25, 2016

Keywords provided by Sun Yat-sen University:
IgA nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Uric Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers processed this record on May 25, 2017