Status:
COMPLETED
Study Evaluating Sirolimus in Kidney Transplant Recipients.
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Failure
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Renal function at 12 months assessed by calculated creatinine clearance.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00167947
Start Date
January 1 2005
End Date
July 1 2007
Last Update
March 14 2008
Active Locations (14)
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1
Rome, Lazio, Italy, 00144
2
Rome, Lazio, Italy, 00168
3
Palermo, Sicily, Italy, 90127
4
Bari, Italy, 70100