maintenance of liver transplant
Conditions
Interventions
Product Name: Certican
Product Code: RAD001 Everolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The investigator must ensure that each patient meet all the following inclusion criteria at screening visit: • Male or female 18 - 70 years old • Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor • Patient with a cGFR = 60 and greater or equal than 20mL/min • Patient receiving Prograf® with C0-h level greater than or equal to 3 and = 8 ng/mL, or Neoral® with C0-h level greater or equal to 50 and = to 150 ng/mL or with C2-h level =250 ng/mL and = 650 ng/mL with or without any of the following (MPA or AZA or steroids) • Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 6 months • Patient in whom an allograft biopsy will not be contraindicated • Female capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient meeting any of the following criteria at screening visit will be excluded from the study participation: • Recipient of multiple solid organ transplants • Patient on dialysis • Patient with an identifiable cause of renal dysfunction other than CNI toxicity • Patient with proteinuria greater than or equal to 1.0 g/24h • Patient with any acute rejection within 6 months prior to randomization • Patient with platelet count of = 50,000/mm³ or white blood cell count of = 2,000/mm³ or hemoglobin value = 8 g/dL • Patient who has undergone a liver transplantation for a hepatocellular carcinoma with sign of recurrence • Patient with severe graft dysfunction • HCV positive patient who needs an active anti-viral treatment • HIV positive patient • Patient who is breast feeding • Patient with a current severe systemic infection • Patient who has received an unlicensed drug or therapy within one month prior to study entry • Presence of any hypersensitivity to drugs similar to CerticanTM(e.g. macrolides) • Use of any other immunosuppressive drugs than Prograf®/Neoral®, steroids, azathioprine and MPA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether initiation of CerticanTM together with reduction or discontinuation of CNI in maintenance liver transplant patients with CNI-related renal impairment will significantly improve the renal function. This will be evaluated by comparing change in renal function assessed by calculated Glomerular Filtration Rate (cGFR) from Baseline to Month 6 after randomization between the study group and the control group with continuation of CNI-based regimen. ;Secondary Objective: The secondary objectives are to assess the efficacy and safety of conversion from standard immunosuppression to CerticanTM-based immunosuppression. This will be evaluated by comparisons between the 2 groups at 6 months after randomization for: • Incidence of efficacy failure (Biopsy Proven Acute Rejection (BPAR), graft loss or death) • Incidence of treated BPAR • Patient and graft survival • Safety parameters including : hypertension, diabetes mellitus, hyperlipidemia, anemia, infections and malignancies • Incidence of discontinuation of study medication • Incidence of premature study withdrawal • Incidence of Serious Adverse Event The HCV replication in HCV positive patients will also be explored. ;Primary end point(s): Demonstration of whether initiation of Certican together with reduction or discontinuation of calcineurin inhibitors (Neoral or Prograf), will improve the renal function significantly more than in the control group. The change in renal function is assessed by calculating the glomerular filtration rate (GFR) from baseline to month 6, after randomisation between the study group and the control group. The targeted population is maintenance liver transplant patients with calcineurin inhibitor's-related renal impairment. | — |
Countries
Belgium, Denmark, Finland, Germany, Italy, Spain
Outcome results
None listed