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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: |
NCT00167947 |
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Date of registration:
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09/09/2005 |
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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 to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients. |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00167947 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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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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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 Italy, decresg@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age is older than 18 years.
- End-stage renal disease, with subjects scheduled for kidney transplant.
- Women of childbearing potential must not be pregnant and agree to medically
acceptable method of contraception throughout the treatment period and for 3 months
following discontinuation of assigned treatment.
Other inclusion applies.
Exclusion Criteria:
- Evidence of active systemic or localized major infection.
- Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics,
corticosteroids, basiliximab.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs
other than renal transplant).
- Immunosuppression therapies other than those allowed in the protocol.
- Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or
ketoconazole (all known to interact with SRL) that is not discontinued prior to study
entry.
Other exclusion applies.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Graft vs Host Disease
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Kidney Failure
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Intervention(s)
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Drug: Cyclosporine
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Drug: Rapamune (Sirolimus)
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Drug: Steroids
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Primary Outcome(s)
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To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
[Time Frame: 6 months]
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Secondary ID(s)
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0468E-101629
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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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