Trial Title:
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study
NCT ID:
NCT01423708
Condition:
Liver Failure
Liver Diseases
Liver Cirrhosis
Liver Neoplasms
Conditions: Official terms:
Liver Neoplasms
Liver Diseases
Liver Cirrhosis
Liver Failure
Everolimus
Conditions: Keywords:
Liver Transplantation
Graft Rejection
Graft Survival
Transplantation Immunology
Anti-Rejection Therapy
Immunosuppression
Organ Transplantation
Host vs Graft Reaction
Gastroenterology
Hepatology
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Everolimus
Description:
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.
Arm group label:
Everolimus
Other name:
Certican
Other name:
Afinitor
Other name:
Zortress
Summary:
Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.
Detailed description:
This prospective study was designed to evaluate the feasibility and effectiveness of the
use of Everolimus in the minimization and possible suspension of calcineurin inhibitors
in adult liver transplant patients. The study will take into account a control group
(standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2
Antibodies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female patients between 18 and 70 years of age,
- 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:
- Physical or laboratory abnormalities or mental illness within 2 weeks before
randomization such that, in the opinion of the investigator, may interfere with
participation in the study
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedali Riuniti - Bergamo
Address:
City:
Bergamo
Zip:
24128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Colledan, MD
Phone:
+39 035 269111
Email:
mcolledan@ospedaliriuniti.bergamo.it
Contact backup:
Last name:
Vittorio Corno, MD
Phone:
+39 035 269111
Email:
vcorno@ospedaliriuniti.bergamo.it
Investigator:
Last name:
Michele Colledan, MD
Email:
Principal Investigator
Investigator:
Last name:
Vittorio Corno, MD
Email:
Sub-Investigator
Facility:
Name:
Irccs Ospedale Maggiore Policlinico Di Milano
Address:
City:
Milano
Zip:
20122
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giorgio Rossi, MD
Phone:
+39 02 55031
Email:
giorgio.rossi@unimi.it
Contact backup:
Last name:
Paolo Reggiani, MD
Phone:
+39 02 55031
Email:
paolo.reggiani@policlinico.mi.it
Investigator:
Last name:
Giorgio Rossi, MD
Email:
Principal Investigator
Investigator:
Last name:
Paolo Reggiani, MD
Email:
Sub-Investigator
Facility:
Name:
Ospedale Ca' Granda-Niguarda - Milano
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luciano De Carlis, MD
Phone:
+39 02 64441
Email:
Luciano.DeCarlis@ospedaleniguarda.it
Contact backup:
Last name:
Jacopo Mangoni, MD
Phone:
+39 02 64441
Email:
jacopo.mangoni@libero.it
Investigator:
Last name:
Luciano De Carlis, MD
Email:
Principal Investigator
Investigator:
Last name:
Jacopo Mangoni, MD
Email:
Sub-Investigator
Facility:
Name:
Azienda Ospedaliera di Padova
Address:
City:
Padua
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Umberto Cillo, MD
Phone:
+390498218624
Email:
cillo@unipd.it
Contact backup:
Last name:
Laura Saracino, MBS
Phone:
+390498218624
Email:
lasaracino@gmail.com
Investigator:
Last name:
Umberto Cillo, MD
Email:
Principal Investigator
Investigator:
Last name:
Giacomo Zanus, MD
Email:
Sub-Investigator
Investigator:
Last name:
Daniele Neri, MD
Email:
Sub-Investigator
Investigator:
Last name:
Patrizia Boccagni, MD
Email:
Sub-Investigator
Investigator:
Last name:
Francesco D'Amico, MD
Email:
Sub-Investigator
Investigator:
Last name:
Enrico Gringeri, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alessandro Vitale, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pasquale Bonsignore, MD
Email:
Sub-Investigator
Investigator:
Last name:
Paolo Feltracco, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dino Sgarabotto, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Marchini, MD
Email:
Sub-Investigator
Investigator:
Last name:
Angelica Magrofuoco, CCTC
Email:
Sub-Investigator
Investigator:
Last name:
Laura Saracino, MSc
Email:
Sub-Investigator
Facility:
Name:
Policlinico Universitario Gemelli Di Roma
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Salvatore Agnes, MD
Phone:
+39 06 3550 1928
Email:
salvatoreagnes@rm.unicatt.it
Contact backup:
Last name:
Erida Nure, MD
Phone:
+39 06 3550 1928
Email:
eridanure@yahoo.it
Investigator:
Last name:
Erida Nure, MD
Email:
Sub-Investigator
Investigator:
Last name:
Salvatore Agnes, MD
Email:
Principal Investigator
Facility:
Name:
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mauro Salizzoni, MD
Phone:
+39 011 633 1633
Email:
msalizzoni@molinette.piemonte.it
Contact backup:
Last name:
Francesco Lupo, MD
Phone:
+39 011 633 1633
Email:
flupo@molinette.piemonte.it
Investigator:
Last name:
Mauro Salizzoni, MD
Email:
Principal Investigator
Investigator:
Last name:
Francesco Lupo, MD
Email:
Sub-Investigator
Facility:
Name:
A.O. Universitaria S. Maria Della Misericordia Di Udine
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Bresàdola, MD
Phone:
+39 0432 5521
Email:
fabrizio.bresadola@dsc.uniud.it
Contact backup:
Last name:
Umberto Baccarani, MD
Phone:
+39 0432 5521
Email:
umberto.baccarani@dsc.uniud.it
Investigator:
Last name:
Umberto Baccarani, MD
Email:
Sub-Investigator
Investigator:
Last name:
Fabio Bresàdola, MD
Email:
Principal Investigator
Start date:
February 2010
Completion date:
January 2014
Lead sponsor:
Agency:
Azienda Ospedaliera di Padova
Agency class:
Other
Source:
Azienda Ospedaliera di Padova
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01423708
http://www.fegatochirurgia.com/
