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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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19 February 2015 |
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Main ID: |
NCT00282217 |
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Date of registration:
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24/01/2006 |
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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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Study Evaluating Sirolimus in the Treatment of Kidney Transplant
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Scientific title:
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Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00282217 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, infomed@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Renal transplantation
- Biopsy-confirmed chronic rejection
- Treatment with mofetil mycophenolate among cyclosporine or tacrolimus
Exclusion Criteria:
- Transplant of any organ other than the kidney
- Current important infection
- Acute rejection within 12 weeks prior to inclusion
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Diseases
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Kidney Failure
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus
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Secondary Outcome(s)
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Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria
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Cumulative incidence of biopsy-confirmed acute rejection at 12 months
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Histological parameters at 12 months
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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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