Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study
NCT ID: NCT01423708
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
117 participants
INTERVENTIONAL
2010-02-28
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Standard immunosuppression protocol with Tacrolimus, maintaining trough levels between 6 and 12 ng/ml in the first month, in association with steroids (20 mg/day with subsequent weaning within 3 months after transplantation).
No interventions assigned to this group
Everolimus
Administration of Everolimus in association with Tacrolimus and steroids.
Everolimus
Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.
Interventions
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Everolimus
Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing de novo liver transplantation from cadaveric donor with a functional graft at the time of randomization,
* Transplantation from cadaveric donor whole or split liver,
* Patients able to communicate properly with the study investigators, to understand and respond to the needs of the protocol and who have given written consent
* Cold ischemia time \<12 hours
Exclusion Criteria
* Women who are pregnant (positive test with hCG values\> 5mUI/ml) or breast-feeding
* Women of childbearing potential, with the following exceptions: a) women in menopause (spontaneous amenorrhea for at least 12 months, spontaneous amenorrhea for at least 6 months with FSH levels \>40 mIU/ml, surgical bilateral oophorectomy at least 6 weeks before baseline, with or without hysterectomy) b) women who use one or more reliable and approved methods of contraception for the duration of the study and for the three months following discontinuation of study treatment.
* Patients who undergo transplantation or multivisceral transplantation of pancreatic islets, or who have previously undergone organ transplantation or tissue.
* Patients who undergo combined liver-kidney transplantation
* Patients who undergo living donor liver transplantation
* Patients who undergo ABO-incompatible liver transplantation
* Patients who undergo transplantation from donors positive for HBV surface antigen or HIV
* History of malignant disease at any site in the 3 year period prior, regardless of whether or not there is evidence of recurrence or metastasis. (Except non-metastatic skin cancers such as basal cell or squamous cell carcinoma of the skin, or hepatocellular carcinoma)
* Patients receiving other investigational drugs within 4 weeks before baseline or who are currently enrolled in other clinical trials
* Patients who show hypersensitivity to the drug (or drugs similar to Everolimus - Former macrolides) or class or pharmaceutical excipients. Also, when there are contraindications
* A history of coagulopathy or the presence of any medical condition that requires long-term anticoagulant therapy after transplantation (The use of low-dose ASA is admissible)
* Platelet count \<=40.000/mm3 or WBC count \<2000/mm3 or hemoglobin \<=7g/dl at the time of randomization
* Severe systemic infections
* High cholesterol levels (\>350mg/dl) or severe hypertriglyceridemia (\>500mg/dl). Patients with compensated hyperlipidemia are eligible.
* Diagnosis of pre-transplant autoimmune liver disease (PBC, sclerosing cholangitis)
* Acute Liver Failure
18 Years
70 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Padova
OTHER
Responsible Party
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Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Principal Investigators
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Umberto Cillo, MD
Role: STUDY_CHAIR
Azienda Ospedaliera di Padova
Locations
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Ospedali Riuniti - Bergamo
Bergamo, BG, Italy
Irccs Ospedale Maggiore Policlinico Di Milano
Milan, MI, Italy
Ospedale Ca' Granda-Niguarda - Milano
Milan, MI, Italy
Azienda Ospedaliera di Padova
Padua, PD, Italy
Policlinico Universitario Gemelli Di Roma
Roma, RM, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Torino, TO, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, UD, Italy
Countries
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Central Contacts
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Facility Contacts
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Michele Colledan, MD
Role: primary
Vittorio Corno, MD
Role: backup
Giorgio Rossi, MD
Role: primary
Paolo Reggiani, MD
Role: backup
Luciano De Carlis, MD
Role: primary
Jacopo Mangoni, MD
Role: backup
Umberto Cillo, MD
Role: primary
Laura Saracino, MBS
Role: backup
Salvatore Agnes, MD
Role: primary
Erida Nure, MD
Role: backup
Mauro Salizzoni, MD
Role: primary
Francesco Lupo, MD
Role: backup
Fabio Bresàdola, MD
Role: primary
Umberto Baccarani, MD
Role: backup
Related Links
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Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)
Other Identifiers
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2009-016176-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1956P
Identifier Type: -
Identifier Source: org_study_id