Overview

Study Evaluating Sirolimus in Kidney Transplant Recipients.

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
Renal function at 12 months assessed by calculated creatinine clearance.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Cyclosporine
Cyclosporins
Everolimus
Sirolimus
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.