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

Liver Transplantation Clinical Trial

Official title:

A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00086346
• Other study ID #: 0468H1-313
• Status: Terminated
• Phase: Phase 3
• First received: June 30, 2004
• Last updated: April 20, 2010
• Start date: December 2002
• Est. completion date: July 2008

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Portugal: National Pharmacy and Medicines InstituteSpain: Ministry of HealthSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 607
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Sirolimus (Rapamune)

• Cyclosporine or Tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)	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.	Baseline and 12 months	No
Primary	Patient and Graft Survival	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.	12 months	Yes
Secondary	Number of Patients With a Biopsy Confirmed Acute Rejection	Overall event rate is determined as yes or no.	12 months	Yes
Secondary	Mean Serum Creatinine	Observed mean values for serum creatinine.	12 months	No