Clinical trial NCT01625377: A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
Official title: A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Everolimus,
liver transplantation,
early introduction,
renal function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.

The renal function was estimated by glomerular filtration rate.


Eligibility criteria: Key Inclusion Criteria:

* Man or woman aged 18 years or greater, recipient of a primary liver transplant from a deceased donor with whole or split liver

Key Exclusion Criteria:

* Patient recipient of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant
* Recipient of a liver from a living donor or cadaveric non heart beating donor
* ABO incompatible transplant graft
* Transplantation following autoimmune liver hepatitis, primitive sclerosing cholangitis or primitive biliary cirrhosis
* Estimated glomerular filtration rate ≤ 30ml/min at selection
* History of malignancy within the 5 past years, other than non-metastatic basal or squamous cell carcinoma and hepatocellular carcinoma
* Alpha-foeto-protein \> 1000 ng/ml (only in case of hepatocellular carcinoma)

Primary outcomes:
measure: Change From Baseline (Randomization) in Renal Function
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Number of Patients With Treatment Failures
timeFrame: At week 12 and week 24
measure: Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)
timeFrame: at 12 week and 24 week
measure: Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification
timeFrame: at 12 week and 24 week
measure: Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3
timeFrame: At 24 weeks
measure: Number of Patients With Death or Graft Loss
timeFrame: at week 24
measure: Change From Baseline (Randomization) in Serum Creatinine
timeFrame: Baseline, Week 24
measure: Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio
timeFrame: Baseline, week 24
measure: Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula
timeFrame: Baseline, Week 24
measure: Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula
timeFrame: Baseline, Week 24
measure: Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula
timeFrame: Baseline, Week 24
measure: Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System
timeFrame: At Week 24
measure: Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Besancon cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Chambray les Tours
country: France
facility: Novartis Investigative Site
city: Clichy
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris Cedex 13
country: France
facility: Novartis Investigative Site
city: Rennes Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 4
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: