Study Evaluating Sirolimus in Kidney Transplant Recipients.
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure; Graft vs Host Disease
Intervention: Cyclosporine (Drug); Steroids (Drug); Rapamune (Sirolimus) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Italy, decresg@wyeth.com
Summary
Renal function at 12 months assessed by calculated creatinine clearance.
Clinical Details
Official title: 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.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
BARI 70100, Italy
Bologna 40138, Italy
Cagliari 09125, Italy
FIRENZE 50139, Italy
L'Aquila 67100, Italy
Milano 20162, Italy
Pisa 56100, Italy
SIENA 53100, Italy
Udine 37100, Italy
Varese 21100, Italy
Sassari 07100, Italy
Roma, Lazio 00168, Italy
Roma, Lazio 00144, Italy
Palermo, Sicily 90127, Italy
Additional Information
Starting date: January 2005
Ending date: July 2007
Last updated: March 13, 2008
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