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

Zhi-Hong Liu, M.D.

Status: Completed

Conditions: IgA Nephropathy (IgAN)

Treatments: Drug: mycophenolate mofetil plus lower dose of Prednisone; Drug: Prednisone in full dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01269021

NJCT-1005

Details and patient eligibility

About

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.

Full description

To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).

Enrollment: 176 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

mycophenolate mofetil

Experimental group

Treatment:

Drug: mycophenolate mofetil plus lower dose of Prednisone

Prednisone

Active Comparator group

Treatment:

Drug: Prednisone in full dose