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

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00793585
First received: November 17, 2008
Last updated: June 6, 2011
Last verified: October 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793585

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

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov 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: June 6, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
IgA nephropathy

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Allopurinol
Uric Acid
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013