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

NCT ID: NCT01269021

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-04-30

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).

Conditions

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IgA Nephropathy (IgAN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mycophenolate mofetil

Group Type EXPERIMENTAL

mycophenolate mofetil plus lower dose of Prednisone

Intervention Type DRUG

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

Prednisone

Group Type ACTIVE_COMPARATOR

Prednisone in full dose

Intervention Type DRUG

0.8-1mg/kg/d

Interventions

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mycophenolate mofetil plus lower dose of Prednisone

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

Intervention Type DRUG

Prednisone in full dose

0.8-1mg/kg/d

Intervention Type DRUG

Other Intervention Names

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MMF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhi-Hong Liu, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Zhi-Hong Liu, M.D.

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhihong Liu, Master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Institute of Nephrology

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJCT-1005

Identifier Type: -

Identifier Source: org_study_id

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