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A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Phase 3
18 Years
70 Years
Open (Enrolling)
Liver Transplantation

Thank you

Trial Information

A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Inclusion Criteria:

- Ability and willingness to provide written informed consent and adhere to study

- Recipients who are 18-70 years of age of a primary liver transplant from a deceased

- Recipients who have been initiated on an immunosuppressive regimen that contains
corticosteroids and tacrolimus, 3-7 days post-transplantation.

- Confirmed recipient HCV status at Screening (either by antibody or by PCR (Polymerase
Chain Reaction).

- Allograft is functioning at an acceptable level by the time of randomization as
defined by protocol specific laboratory values.

- Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Results obtained within 5 days prior to
randomization are acceptable, however no sooner than Day 25 post-transplantation.

- Verification of at least one tacrolimus trough level of ≥ 8 ng/mL in the week prior
to randomization. Investigators should make adjustments in tacrolimus dosing to
continue to target trough levels above 8 ng/mL prior to randomization.

Exclusion Criteria

- Patients who are recipients of multiple solid organ or islet cell tissue transplants,
or have previously received an organ or tissue transplant. Patients who have a
combined liver-kidney transplant.

- Recipients of a liver from a living donor, or of a split liver.

- History of malignancy of any organ system within the past 5 years whether or not
there is evidence of local recurrence or metastases, other than non-metastatic basal
or squamous cell carcinoma of the skin, or HCC (Hepatocellular Carcinoma) (see next

- Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤5 cm, 2-3
nodules all <3 cm) at the time of transplantation as per explant histology of the
recipient liver.

- Any use of antibody induction therapy.

- Patients with a known hypersensitivity to the drugs used on study or their class, or
to any of the excipients

- Patients who are recipients of ABO incompatible transplant grafts.

- Recipients of organs from donors who test positive for Hepatitis B surface antigen or
HIV are excluded.

- Patients who have any surgical or medical condition, which in the opinion of the
investigator, might significantly alter the absorption, distribution, metabolism and
excretion of study drug.

- Women of child-bearing potential (WOCBP)

- Patients with any history of coagulopathy or medical condition requiring long-term
anticoagulation which would preclude liver biopsy after transplantation. (Low dose
aspirin treatment or interruption of chronic anticoagulant is allowed).

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

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

Outcome Measure:

Assessment of renal function by Estimated Glomerular Filtration Rate,eGFR , using abbreviated Modification of Diet in Renal Disease at 12-mths post-transplantation Composite efficacy failure of death,graft loss,or loss to follow-up at 12-mths post-trans.

Outcome Time Frame:

12 months post-transplantation

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Italy: The Italian Medicines Agency

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Liver Transplantation
  • Liver transplantation
  • everolimus
  • calcineurin inhibitors
  • tacrolimus
  • renal function
  • MDRD formula
  • progression of fibrosis



Baylor College of Medicine Houston, Texas  77030
UCSF San Francisco, California  941430324
Washington University School of Medicine Saint Louis, Missouri  63110
Medical University of South Carolina Charleston, South Carolina  29425-0721
Cedars-Sinai Medical Center Los Angeles, California  90048
Piedmont Hospital Atlanta, Georgia  30309
Methodist Hospital Houston, Texas  77030
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
Georgetown University Washington, District of Columbia  20007-2197
Oregon Health Sciences University Portland, Oregon  
Cleveland Clinic Cleveland, Ohio  44195
University of Chicago Medical Center Chicago, Illinois  60637
University of Texas Health Science Center San Antonio, Texas  78284
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
UCLA Los Angeles, California  90095
University of Kentucky Lexington, Kentucky  40536-0098
New York University New York, New York  10016
Hershey Medical Center Hershey, Pennsylvania  17033
Integris Baptist Medical Center Oklahoma City, Oklahoma  73112
Columbia University Medical Center New York, New York  10032
Lahey Clinic Medical Center Burlington, Massachusetts  01805
Memorial Hermann Hospital Houston, Texas  77030
John Hopkins University Baltimore, Maryland  21231
University of Southern CA Los Angeles, California  90033
University of Colorado / Anchutz Cancer Pavilion Aurora, Colorado  80045
Miami School of Medicine Miami, Florida  33136
Lifelink, Inc Tampa, Florida  33606
Willis Knighton - LSU HSC Shreveport, Louisiana  71103
U of Maryland Medical Center Baltimore, Maryland  21201
Henry Ford Hospital Transplant Institute Detroit, Michigan  48202
University of Minnesota Research Services Org Minneapolis, Minnesota  55414
Mayo Clinic Transplant Center Rochester, Minnesota  55905
UMD, Division of Transplant Surgery Newark, New Jersey  07101
Vanderbuilt Transplant Center Nashville, Tennessee  37232
The Baylor College of Medicine Dallas, Texas  75203
Methodist Dallas Liver Insititute Dallas, Texas  75203