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

Study Overview
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Brief Summary
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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.

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

Official Title
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Conditions
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IgA Nephropathy (IgAN)

Intervention / Treatment
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* Drug: mycophenolate mofetil plus lower dose of Prednisone
* Drug: Prednisone in full dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mycophenolate mofetil<br> | Drug: mycophenolate mofetil plus lower dose of Prednisone<br>* MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d<br>* Other names: MMF;|
| Active Comparator: Prednisone<br> | Drug: Prednisone in full dose<br>* 0.8-1mg/kg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of complete remission (CR) at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of overall response (CR+ partial remission [PR]) at 6 months |  | 6 months | 
| the median time to CR |  | from the start of enrollment to the day of complete remission | 
| the relapse rate after stopping the treatments |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMF treatment IgA Nephropathy (IgAN)