To provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Product Name: AEB071
Product Code: AEB071
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: sotrastaurin
CAS Number: 425637-18-9
Current Sponsor code: AEB071
Concentration unit: mg milligram(s)
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: • The patient has given written informed consent to participate in the extension study. • The patient has been maintained on AEB071/Certican® or Neoral®/Certican®, consistent with their original randomisation, at their core study Month 12 visit. • Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s), as per [core study protocol]. 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: • Inability or unwillingness to comply with the immunosuppressive regimen or the protocol. • Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to characterise the general and renal-specific glomerular filtration rate (GFR) (MDRD) safety profile, up to 36 months post transplantation, of renal transplant patients treated with AEB071 in combination with Certican® (CNI free) versus a standard CNI-based regimen.;Secondary Objective: to characterise the efficacy profile, composite endpoint of biopsy proven acute rejection (BPAR) = IA, graft loss, death, or lost to follow up, up to 36 months post transplantation, of renal transplant patients treated with AEB071 in combination with Certican® (CNI free) versus a standard CNI based regimen. ;Primary end point(s): The key efficacy parameter is the incidence over 36 months of the composite endpoint of BPAR = 1A, graft loss, death, or lost to follow-up in the two study arms. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Slovakia, Spain
Outcome results
None listed