CompletedNot Applicable

An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)

China176 participantsStarted 2010-11

Plain-language summary

In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid . Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Patients who signed written informed consent form
✓. age between 18-60 years, female or male
✓. diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
✓. renal biopsy had: 10%\< crescents\<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis\<50%,
✓. proteinuria\>1g/24h for two times

Exclusion criteria

✕. secondary IgA Nephropathy (IgAN);
✕. eGFR\<30ml/min/1.73m2.( MDRD formula)
✕. liver disfunction;
✕. uncontrolled hypertension
✕. WBC \<3000/mm3
✕. Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
✕. diabetes or obesity(BMI\>28) ;
✕. severe infection or central nervous system symptoms.

What they're measuring

the rate of complete remission (CR) at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT01269021

SponsorZhi-Hong Liu, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10

View on ClinicalTrials.gov More IgA Nephropathy (IgAN) trials