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 (SIMCER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01625377
First received: June 19, 2012
Last updated: June 18, 2014
Last verified: June 2014

June 19, 2012
June 18, 2014
December 2012
April 2015   (final data collection date for primary outcome measure)
Change from baseline in renal function [ Time Frame: randomisation to month 6 post-transplantation ] [ Designated as safety issue: No ]
Change in glomerular filtration rate calculated using the MDRD abbreviated formula
Same as current
Complete list of historical versions of study NCT01625377 on ClinicalTrials.gov Archive Site
  • Treatment failures (biopsy proven acute rejection BPAR, graft loss or death) [ Time Frame: randomization to 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated biopsy proven acute rejection BPAR (score > 3), graft loss or death
  • BPAR [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of BPAR
  • Treated BPAR [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated BPAR
  • Treated BPAR (score > 3) [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated BPAR (score > 3)
  • BPAR (score > 3) [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of BPAR (score > 3)
  • Death or graft loss [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of death or graft loss
  • Change from baseline in renal function [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    change in renal function parameters (creatininemia, eGFR, estimated creatinine clearance, proteinuria, microalbuminuria and proteninuria/microalbuminuria ratio)
  • Assessment of safety [ Time Frame: 3 months and 6 months post-transplantation ] [ Designated as safety issue: Yes ]
    Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs). Incidence of premature study and study treatment discontinuations and discontinuation reasons.
  • Treatment failures (biopsy proven acute rejection BPAR, graft loss or death) [ Time Frame: randomization to 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated biopsy proven acute rejection BPAR (score > 3), graft loss or death
  • BPAR [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of BPAR
  • Treated BPAR [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated BPAR
  • Treated BPAR (score > 3) [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of treated BPAR (score > 3)
  • BPAR (score > 3) [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of BPAR (score > 3)
  • Death or graft loss [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    Incidence of death or graft loss
  • Change from baseline in renal function [ Time Frame: 3 months and 6 months after transplantation ] [ Designated as safety issue: No ]
    change in renal function parameters (creatininemia, eGFR, estimated creatinine clearance, proteinuria, microalbuminuria and proteninuria/microalbuminuria ratio)
  • Assessment of safety [ Time Frame: 3 months and 6 months post-transplantation ] [ Designated as safety issue: Yes ]
    Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs). Incidence of premature study and study treatment discontinuations and discontinuation reasons.
Not Provided
Not Provided
 
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
Etude Nationale Multicentrique, randomisée, en Ouvert, évaluant l'efficacité et la tolérance de l'évérolimus associé au mycophénolate Sodique, en Comparaison à un Traitement Standard Associant Tacrolimus et mycophénolate Sodique Chez Des Patients Adultes transplantés hépatiques de Novo

The aims of the study are 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 is estimated by glomerular filtration rate.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplantation
  • Drug: tacrolimus
    Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
    Other Name: Prograf®
  • Drug: everolimus
    Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
    Other Name: Certican® / RAD001
  • Active Comparator: Control group (Arm 1)
    From transplantation to randomization: Simulect® (40mg) at D0 and D4 + Prograf® (C0 6-10 ng/ml) from D3-D5 + Myfortic® 1440 mg/d ± steroids From randomization to month 6 : Prograf® (C0 6-10 ng/ml) + Myfortic® 1440 mg/d ± steroids
    Intervention: Drug: tacrolimus
  • Experimental: Everolimus (Arm 2)
    From transplantation to randomization: Simulect® (40mg) at D0 and D4 + Prograf® (C0 6-10 ng/ml) from D3-D5 + Myfortic® 1440 mg/d ± steroids From randomization to month 6 : Certican® (C0 6-10 ng/ml) + Myfortic® 1440 mg/d ± steroids
    Interventions:
    • Drug: tacrolimus
    • Drug: everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
205
April 2015
April 2015   (final data collection date for primary outcome measure)

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

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) Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
France
 
NCT01625377
CRAD001HFR02, 2012-000137-39
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP