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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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18 April 2017 |
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Main ID: |
ChiCTR-TRC-10000776 |
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Date of registration:
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2010-02-10 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy
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Scientific title:
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A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy |
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Date of first enrolment:
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2010-02-27 |
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Target sample size:
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1:100;2:100;3:100;4:100; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8760 |
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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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Post-market
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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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Jie Wu
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Address:
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28 Fuxing Road, Beiiing, China
100853
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Telephone:
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+86 010 66937011 |
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Email:
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wujie301@hotmail.com |
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Affiliation:
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Chinese General Hospital of PLA |
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Name:
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Xiangmei Chen
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Address:
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28 Fuxing Road, Beiiing, China
100853
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Telephone:
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+86 010 66935462 |
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Email:
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xmchen301@126.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Renal biopsy proven lgA nephropathy in 1 year, grade of Lee II-IV;
2. Age range 18-55 years, male and female;
3. BP<=130/80mmHg (with or without drug);
4. Proteinuria levels of 0.5 to 3.5g/24hr;
5. Scr<265.2umol/L(3mg/dl);
6. To sign informed consent.
Exclusion criteria: 1. History of hypersensitivity to experiment medicine;
2. BP<90/60mmHg;
3. suckle, and known or suspected pregnancy;
4. leukocyte counts <=3.0*10^9/L,or >10*10^9/L;
5. secondary lgA nephropathy;
6. steroids and immunosuppressive drugs treatment during previous 3 months.
Age minimum:
18
Age maximum:
55
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ICD:N03.8
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lgA nephropathy
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Intervention(s)
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1:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide;
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Primary Outcome(s)
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Urine Protein;
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Secondary Outcome(s)
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Renal function, eGFR, plasma-albumin;
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Source(s) of Monetary Support
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Science and Technology fund of Beijing finance
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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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