IgA Nephropathy (IgAN) Clinical Trial
Official title:
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Verified date | March 2016 |
Source | Nanjing University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 176 |
Est. completion date | April 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Research Institute of Nephrology | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Zhi-Hong Liu, M.D. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the rate of complete remission (CR) at 6 months | 6 months | Yes | |
Secondary | the rate of overall response (CR+ partial remission [PR]) at 6 months | 6 months | Yes | |
Secondary | the median time to CR | from the start of enrollment to the day of complete remission | Yes | |
Secondary | the relapse rate after stopping the treatments | 12 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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Phase 2 | |
Completed |
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