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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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ChiCTR |
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Last refreshed on:
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21 August 2017 |
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Main ID: |
ChiCTR-INR-17012212 |
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Date of registration:
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2017-08-01 |
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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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Use of sirolimus in patients with primary idiopathic membranous nephropathy: a prospective randomized control trial
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Scientific title:
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Use of sirolimus in patients with primary idiopathic membranous nephropathy: a prospective randomized control trial |
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Date of first enrolment:
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2017-07-28 |
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Target sample size:
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1:35;2:35; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=20792 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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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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Fang Wang
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Address:
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8 Xishiku Street, Xicheng District, Beijing, China
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Telephone:
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+86 010-83575755 |
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Email:
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wangfang@bjmu.edu.cn |
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Affiliation:
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Renal Division, Peking University First Hospital |
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Name:
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Minghui Zhao
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Address:
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8 Xishiku Street, Xicheng District, Beijing, China
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Telephone:
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+86 010-83572388 |
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Email:
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mhzhao@bjmu.edu.cn |
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Affiliation:
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Renal Division, Peking University First Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. aged 18-70 years;
2. diagnosed as idiopathic membranous nephropathy by renal biopsy;
3. corticosteroids and immunosuppressive agents were not received in the recent 3 months;
4. blood pressure <140/90mmHg;
5. proteinuria =3.5g/day and eGFR= 45ml/min /1.73m2, with at least 3-month treatment of maximum tolerance dasage of ACEI/ARB;
6. serum creatinie =133umol/L;
7. agree to sign informed consent
Exclusion criteria: 1. any type of secondary membranous nephropathy by renal biopsy;
2. any other tyoe of kidney disease;
3. uncontrolled infection;
4. Interstitial pneumonia;
5. new onset of cadiovascular disease in recent 3 months;
6. severe liver disease, liver enzyme elevation is not higher than 3 times;
7. uncontrolled severe hypertension;
8. A new or recurring malignancy within 8.5 years;
9. peptic ulcer or active digestive tract bleeding;
10. severe autoimmune disease;
11. pregnancy, lactation or scheduled pregnancy;
12. expected survival was less than December;
13. other clinical studies are currently in progress;
14. do not agree to sign informed consent;
15. the researchers found other conditions unsuitable for the study.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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idiopathic membranous nephropathy
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Intervention(s)
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1:Cyclosporine;2:cyclosporine combined with sirolimus;
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Primary Outcome(s)
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proteinuria;
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Source(s) of Monetary Support
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Huabei Pharmaceutical Company.
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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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