Back to resultsAn Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
Primary Purpose
IgA Nephropathy (IgAN)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mycophenolate mofetil plus lower dose of Prednisone
Prednisone in full dose
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy (IgAN) focused on measuring MMF treatment IgA Nephropathy (IgAN)
Eligibility Criteria
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.
Sites / Locations
- Research Institute of Nephrology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mycophenolate mofetil
Prednisone
Arm Description
Outcomes
Primary Outcome Measures
the rate of complete remission (CR) at 6 months
Secondary Outcome Measures
the rate of overall response (CR+ partial remission [PR]) at 6 months
the median time to CR
the relapse rate after stopping the treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01269021
Brief Title
An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
Official Title
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy (IgAN)
Keywords
MMF treatment IgA Nephropathy (IgAN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mycophenolate mofetil
Arm Type
Experimental
Arm Title
Prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil plus lower dose of Prednisone
Other Intervention Name(s)
MMF
Intervention Description
MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d
Intervention Type
Drug
Intervention Name(s)
Prednisone in full dose
Intervention Description
0.8-1mg/kg/d
Primary Outcome Measure Information:
Title
the rate of complete remission (CR) at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the rate of overall response (CR+ partial remission [PR]) at 6 months
Time Frame
6 months
Title
the median time to CR
Time Frame
from the start of enrollment to the day of complete remission
Title
the relapse rate after stopping the treatments
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, Master
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
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