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.