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

Not Applicable

Completed

• Conditions: IgA Nephropathy (IgAN)
• Interventions: Drug: Prednisone in full dose; Drug: mycophenolate mofetil plus lower dose of Prednisone

• Registration Number: NCT01269021
• Lead Sponsor: Zhi-Hong Liu, M.D.

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone in full dose	-
mycophenolate mofetil	mycophenolate mofetil plus lower dose of Prednisone	-

Primary Outcome Measures

Name	Time	Method
the rate of complete remission (CR) at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
the relapse rate after stopping the treatments	12 months
the median time to CR	from the start of enrollment to the day of complete remission
the rate of overall response (CR+ partial remission [PR]) at 6 months	6 months

Trial Locations

Locations (1)

Research Institute of Nephrology; 🇨🇳 Nanjing, Jiangsu, China