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
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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COMPLETED
NA
176 participants
INTERVENTIONAL
2010-11-30
2014-04-30
Brief Summary
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Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mycophenolate mofetil
mycophenolate mofetil plus lower dose of Prednisone
MMF 1.0-1.5g/d\*6mons Prednisone 0.4-0.6 mg/kg/d
Prednisone
Prednisone in full dose
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
Prednisone in full dose
0.8-1mg/kg/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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Zhi-Hong Liu, M.D.
OTHER
Responsible Party
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Zhi-Hong Liu, M.D.
professor
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
Countries
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Other Identifiers
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NJCT-1005
Identifier Type: -
Identifier Source: org_study_id
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