Study Evaluating Sirolimus in Kidney Transplant Recipients.
NCT ID: NCT00167947
Last Updated: 2008-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2005-01-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Steroids
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Rapamune (Sirolimus)
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Cyclosporine
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
B
Steroids
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Rapamune (Sirolimus)
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Cyclosporine
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Interventions
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Steroids
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Rapamune (Sirolimus)
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Cyclosporine
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Rome, Lazio, Italy
Rome, Lazio, Italy
Palermo, Sicily, Italy
Bari, , Italy
Bologna, , Italy
Cagliari, , Italy
Florence, , Italy
L’Aquila, , Italy
Milan, , Italy
Pisa, , Italy
Sassari, , Italy
Siena, , Italy
Udine, , Italy
Varese, , Italy
Countries
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Other Identifiers
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0468E-101629
Identifier Type: -
Identifier Source: org_study_id
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