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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01269021

Enrollment

176

Registered

2011-01-04

Start date

2010-11-30

Completion date

2014-04-30

Last updated

2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy (IgAN)

Keywords

MMF treatment IgA Nephropathy (IgAN)

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).

Interventions

DRUGmycophenolate mofetil plus lower dose of Prednisone

MMF 1.0-1.5g/d\*6mons Prednisone 0.4-0.6 mg/kg/d

DRUGPrednisone in full dose

0.8-1mg/kg/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
the rate of complete remission (CR) at 6 months	6 months

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026