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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)
Both
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
regimen.

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

- 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
criteria).

- 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:

Interventional

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:

No

Principal Investigator

Novartis

Investigator Role:

Study Director

Investigator Affiliation:

Novartis

Authority:

Italy: The Italian Medicines Agency

Study ID:

CRAD001H2304

NCT ID:

NCT00622869

Start Date:

January 2008

Completion Date:

Related Keywords:

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

Name

Location

Baylor College of MedicineHouston, Texas  77030
UCSFSan Francisco, California  941430324
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Cedars-Sinai Medical CenterLos Angeles, California  90048
Piedmont HospitalAtlanta, Georgia  30309
Methodist HospitalHouston, Texas  77030
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
Georgetown UniversityWashington, District of Columbia  20007-2197
Oregon Health Sciences UniversityPortland, Oregon  
Cleveland ClinicCleveland, Ohio  44195
University of Chicago Medical CenterChicago, Illinois  60637
University of Texas Health Science CenterSan Antonio, Texas  78284
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
UCLALos Angeles, California  90095
University of KentuckyLexington, Kentucky  40536-0098
New York UniversityNew York, New York  10016
Hershey Medical CenterHershey, Pennsylvania  17033
Integris Baptist Medical CenterOklahoma City, Oklahoma  73112
Columbia University Medical CenterNew York, New York  10032
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Memorial Hermann HospitalHouston, Texas  77030
John Hopkins UniversityBaltimore, Maryland  21231
University of Southern CALos Angeles, California  90033
University of Colorado / Anchutz Cancer PavilionAurora, Colorado  80045
Miami School of MedicineMiami, Florida  33136
Lifelink, IncTampa, Florida  33606
Willis Knighton - LSU HSCShreveport, Louisiana  71103
U of Maryland Medical CenterBaltimore, Maryland  21201
Henry Ford Hospital Transplant InstituteDetroit, Michigan  48202
University of Minnesota Research Services OrgMinneapolis, Minnesota  55414
Mayo Clinic Transplant CenterRochester, Minnesota  55905
UMD, Division of Transplant SurgeryNewark, New Jersey  07101
Vanderbuilt Transplant CenterNashville, Tennessee  37232
The Baylor College of MedicineDallas, Texas  75203
Methodist Dallas Liver InsitituteDallas, Texas  75203