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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 October 2017 |
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Main ID: |
NCT00195273 |
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Date of registration:
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12/09/2005 |
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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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Study Evaluating Sirolimus in Kidney Transplant Recipients
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Scientific title:
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A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00195273 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Norway
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Sweden
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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 Norway, Sweden, MedInfoNord@wyeth.com |
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Name:
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Medical Monitor, MD |
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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:
- Kidney transplantation
- Donor must be at least 60 years old.
Exclusion Criteria:
- Current systemic infection
- Unstable angina or treatment for serious arrhythmia.
- Cancer within the previous 5 years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Graft vs Host Disease
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Kidney Transplantation
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Intervention(s)
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Drug: daclizumab
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Drug: corticosteroids
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Drug: cyclosporine
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Drug: sirolimus
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Drug: mycophenolate mofetil
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Primary Outcome(s)
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Mean Creatinine Clearance Rate
[Time Frame: 12 months]
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Secondary Outcome(s)
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Number of Patients With Acute Rejection
[Time Frame: 3 and 12 months]
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Mean Creatinine Clearance Rate - 3 Months
[Time Frame: 3 months]
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Patient and Graft Survival
[Time Frame: 12 months]
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Secondary ID(s)
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0468H-101466
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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