Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Completed · Phase 3

Conditions studied: Liver Transplantation

In brief

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Key facts

Study ID

NCT01888432

Run by

Novartis Pharmaceuticals

People needed

285

Starts

2013-09-25

Expected to finish

2018-04-21

Last updated by the study team

2019-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor
• Subject negative for HIV
• Incusion criteria at Randomization:
• Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression

You may not qualify if…

• Subjects transplanted for acute liver failure
• HCV negativesubjects receiving a transplant from HCV positive donor
• Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
• Subjects receiving an ABO incompatible allograft.
• MELD-score > 35 within 1 month prior to transplantation.
• Use of immunosuppressive or antibody induction agents not specified in the protocol.
• History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin)
• Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients
• Exclusion criteria at Randomization:
• Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
• Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria
• Subjects who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL; >5.6 mmol/L) at randomization.
• Subjects with platelet count < 30,000/mm3.
• Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
• Subjects with systemic infection requiring active use of IV antibiotics.
• Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents.
• Subjects who require renal replacement therapy within 7 days prior to randomization.
• Subjects with detectable HBV DNA at time of randomization
• Subjects meeting the following criteria for acute rejection during the run in period:
• Any acute rejection in the week prior to randomization.
• 2 treated acute rejections.
• Any rejection requiring antibody treatment.

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Burlington, Massachusetts, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Charlottesville, Virginia, United States
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Cairo, Egypt
• Novartis Investigative Site — Regensburg, Bavaria, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Jena, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Gurgaon, Haryana, India
• Novartis Investigative Site — Kochi, Kerala, India
• Novartis Investigative Site — Chennai, Tamil Nadu, India
• Novartis Investigative Site — Chennai, Tamil Nadu, India
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Fukuoka, Fukuoka, Japan
• Novartis Investigative Site — Hiroshima, Hiroshima, Japan
• Novartis Investigative Site — Kumamoto, Kumamoto, Japan
• Novartis Investigative Site — Sakyo Ku, Kyoto, Japan

Full record on ClinicalTrials.gov

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