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

March 15, 2016 updated by: Zhi-Hong Liu, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of complete remission (CR) at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhi-Hong Liu, M.D.

Investigators

  • Principal Investigator: Zhihong Liu, Master, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-1005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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