Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: Sirolimus (Rapamune); Drug: Cyclosporine or Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00086346

0468H1-313

Details and patient eligibility

About

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

Enrollment: 607 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 13 years (age greater than 18 years as required by some local regulations).
• Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
• 6 to 144 months after orthotopic liver transplantation.
• Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

Exclusion criteria

• History of nonhepatic transplantation
• Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
• Known or suspected malignancy < 5 years before random assignment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

607 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Sirolimus (Rapamune)

B

Active Comparator group

Treatment:

Drug: Cyclosporine or Tacrolimus