Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: April 23, 2010
Last updated: September 14, 2013
Last verified: September 2013

The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

Condition Intervention Phase
Liver Transplant Recipient
Drug: Tacrolimus
Drug: Tacrolimus + everolimus
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assessment of renal function by Estimated Glomerular Filtration Rate. Efficacy failure as treated biopsy proven acute rejection (BPAR ), graft loss or death. Rate of progression of HCV related allograft fibrosis [ Time Frame: at 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of hypertension, neurotoxicity, or new-onset diabetes mellitus (NODM) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: April 2010
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus Drug: Tacrolimus
Experimental: Low dose tacrolimus + everolimus Drug: Tacrolimus + everolimus
Experimental: Everolimus Drug: Everolimus


Ages Eligible for Study:   20 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Ability and willingness to adhere to study regimen
  • Completed core study with assigned regimen

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

  • Severe hypercholesterolemia or hypertriglyceridemia.
  • Low platelet count.
  • Low white blood cell count.
  • Positive test for human immunodeficiency virus (HIV).
  • Systemic infection requiring active use of IV antibiotics.
  • Patients in a critical care setting.
  • Use of prohibited medication.
  • Use of immunosuppressive agents not utilized in the protocol.
  • Hypersensitivity to any of the study drugs or similar drugs.
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential not using a highly effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150097

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of Southern CA
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado / Anchutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
Lifelink, Inc
Tampa, Florida, United States, 33606
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Michigan
Henry Ford Hospital Transplant Institute
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Transplant Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
United States, New Jersey
UMD, Division of Transplant Surgery
Newark, New Jersey, United States, 07101
United States, New York
New York University
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbuilt Transplant Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Dallas, Texas, United States, 75246
Methodist Dallas Liver Insititute
Dallas, Texas, United States, 75203
The Baylor College of Medicine
Dallas, Texas, United States, 75203
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
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Buenos Aires, Argentina
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Rosario, Argentina
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San Martin, Argentina
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Bedford Park, Australia
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Camperdown, Australia
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Heidelburg, Australia
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Nedlands, Australia
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Gent, Belgium
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Leuven, Belgium
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Liege, Belgium
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Blumenau, Brazil
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Porto Alegre, Brazil
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Ribeirao Preto, Brazil
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Rio de Janeiro, Brazil
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, Ontario
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Vancouver, Canada
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Bogota, Colombia
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Cali, Colombia
Czech Republic
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Prague, Czech Republic, 14021
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Bordeaux, France
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Clichy, France
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Creteil, France
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Lille, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Rennes Cedex, France
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Villejuif, France
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Berlin, Germany
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Essen, Germany, 45359
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Hamburg, Germany
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Heidelberg, Germany
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Leipzig, Germany, 04257
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Mainz, Germany
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Regensburg, Germany
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Budapest, Hungary
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Dublin, Ireland
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Milano, Italy
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Modena, Italy
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Pisa, Italy
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Roma, Italy
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Torino, Italy
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Rotterdam, Netherlands
Russian Federation
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Moscow, Russian Federation, 123182
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Moscow, Russian Federation, 129110
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Barakaldo, Spain, 48903
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Barcelona, Spain, 08907
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Barcelona, Spain, 08025
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Hospitalet de Llobregat, Spain, 08907
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Madrid, Spain, 28035
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Madrid, Spain, 28034
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Malaga, Spain, 28041
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Pamplona, Spain, 31008
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Valencia, Spain, 46009
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Stockholm, Sweden
United Kingdom
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Edinburgh, United Kingdom, ED16 4SA
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Leeds, United Kingdom, LS9 7TF
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London, United Kingdom, SE1 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01150097     History of Changes
Other Study ID Numbers: CRAD001H2304E1
Study First Received: April 23, 2010
Last Updated: September 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Liver transplantation
Calcineurin inhibitors
Renal function
Progression of HCV related allograft fibrosis

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014