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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00086346
First received: June 30, 2004
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
 Drug: Sirolimus (Rapamune)
Drug: Cyclosporine or Tacrolimus
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Number of Patients With a Biopsy Confirmed Acute Rejection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Overall event rate is determined as yes or no.

  • Mean Serum Creatinine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Observed mean values for serum creatinine.


Enrollment: 607
Study Start Date: December 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Sirolimus (Rapamune)
Active Comparator: B Drug: Cyclosporine or Tacrolimus

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086346

  Show 42 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedinfo@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00086346     History of Changes
Other Study ID Numbers: 0468H1-313
Study First Received: June 30, 2004
Results First Received: July 6, 2009
Last Updated: April 20, 2010
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute
Spain: Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Liver
Transplant

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013