Study Evaluating Sirolimus in Kidney Transplant Recipients.

Wyeth

Status and phase: Completed; Phase 3

Conditions: Kidney Failure; Graft vs Host Disease

Treatments: Drug: Steroids; Drug: Rapamune (Sirolimus); Drug: Cyclosporine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00167947

0468E-101629

Details and patient eligibility

About

Renal function at 12 months assessed by calculated creatinine clearance.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Rapamune (Sirolimus)

Drug: Steroids

Drug: Cyclosporine

B

Experimental group

Treatment:

Drug: Rapamune (Sirolimus)

Drug: Steroids

Drug: Cyclosporine