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

Phase 3

Terminated

• Conditions: Liver Transplantation
• Interventions: Drug: Sirolimus (Rapamune); Drug: Cyclosporine or Tacrolimus

• Registration Number: NCT00086346
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2004-06-30
• Study First Submitted QC: 2004-07-01
• Study First Posted: 2004-07-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-31
• Results First Posted: 2009-09-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-20
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 607

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Sirolimus (Rapamune)	-
B	Cyclosporine or Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)	Baseline and 12 months	GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is \>90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Patient and Graft Survival	12 months	Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With a Biopsy Confirmed Acute Rejection	12 months	Overall event rate is determined as yes or no.
Mean Serum Creatinine	12 months	Observed mean values for serum creatinine.