Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Last updated: December 1, 2019
Sponsor: Sun Yat-sen University
Overall Status: Completed

Phase

3

Condition

Glomerulonephritis

Kidney Disease

Nephropathy

Treatment

N/A

Clinical Study ID

NCT00657059
SYSU-PRGIgAN-001
  • Ages 14-60
  • All Genders

Study Summary

A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willingness to sign an informed consent

  • Age:14~60 years, regardless of gender

  • Clinical evaluation and renal biopsy diagnostic for IgAN, excluded secondary IgAN.Renal histological criteria should be defined by Lee's glomerular grading system.

  • 1 g/day <= proteinuria < 3.5 g/day, or UPr/Cr ratio ≥ 0.6 (male) or ≥ 0.8 (female)when taking ARB

  • eGFR ≥ 40 mL/min/1.73 m2

Exclusion

Exclusion Criteria:

  • Inability or unwillingness to sign the informed consent

  • Inability or unwillingness to meet the scheme demands raised by the investigators

  • Rapidly progressive nephritic syndrome and acute renal failure, including rapidlyprogressive IgAN ( IgAN with rapid decline in renal function characterizedhistologically by necrotizing vasculitis and crescent formation≥30%) necessitating theuse of other immunosuppressive agents.

  • Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuricnephritis and hepatitis B -associated nephritis

  • est GFR < 40 mL/min/1.73m2

  • Malignant hypertension that is difficult to be controlled by oral drugs

  • Cirrhosis, chronic active liver disease.

  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea oractive peptic ulcer disease.)

  • Any Active systemic infection or history of serious infection within one month ofentry or known infection with HIV, hepatitis B, or hepatitis C.

  • Other major organ system disease (e.g. serious cardiovascular diseases includingcongestive heart failure , chronic obstructive pulmonary disease, asthma requiringoral steroid treatment or central nervous system diseases)

  • Malignant tumors (except fully cured basal cell carcinoma)

  • Absolute neutrophil count < 1500/mm3, absolute platelet count <75000/mm3 or hematocrit (Hct) <28% (anemic subjects may be reevaluated after the anemia has been treated.)

  • Known allergy, contraindication or intolerance to the MMF, corticosteroids orACEI/ARB.

  • Pregnancy or breast feeding at the time of entry or unwillingness to comply withmeasures for contraception

  • Current exposure to MMF or azathioprine. In case of current treatment with oralsteroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stoppedfor 2 weeks.

  • Current or recent (within 30 days) exposure to any other investigational drugs

Study Design

Total Participants: 151
Study Start date:
September 01, 2007
Estimated Completion Date:
May 31, 2019

Study Description

There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.

Connect with a study center

  • The 1st Affiliated Hospital, Sun Yet-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

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