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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT01269021 |
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Date of registration:
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10/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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176 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01269021 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zhihong Liu, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy (IgAN)
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Intervention(s)
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Drug: Prednisone in full dose
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Drug: mycophenolate mofetil plus lower dose of Prednisone
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Primary Outcome(s)
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the rate of complete remission (CR) at 6 months
[Time Frame: 6 months]
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Secondary Outcome(s)
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the median time to CR
[Time Frame: from the start of enrollment to the day of complete remission]
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the relapse rate after stopping the treatments
[Time Frame: 12 months]
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the rate of overall response (CR+ partial remission [PR]) at 6 months
[Time Frame: 6 months]
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Secondary ID(s)
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NJCT-1005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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