Study Evaluating Sirolimus in Kidney Transplant Recipients.

Phase 3

Completed

• Conditions: Kidney Failure; Graft vs Host Disease
• Interventions: Drug: Cyclosporine; Drug: Steroids; Drug: Rapamune (Sirolimus)

• Registration Number: NCT00167947
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Renal function at 12 months assessed by calculated creatinine clearance.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-13
• Last Update Posted: 2008-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Steroids	-
A	Rapamune (Sirolimus)	-
B	Cyclosporine	-
A	Cyclosporine	-
B	Steroids	-
B	Rapamune (Sirolimus)	-

Primary Outcome Measures

Name	Time	Method
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.	6 months