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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

IgA Nephropathy

Treatments

Drug: allopurinol
Other: continue their usual therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00793585
SYSU-PRGIgAN-002

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Allopurinol
Experimental group
Description:
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.
Treatment:
Drug: allopurinol
Control group
Other group
Description:
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.
Treatment:
Other: continue their usual therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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