The study is a continuation of a CNI-sparing study in which 2/3rds of patients were converted to a non CNI regimen after 3 months (core study). The others remained on a CNI Control arm. The extension will allow continued access to AEB071 after the end of the core trial, and also to the control arm patients who were on study treatment at the end of the core study. The data may provide early notification of safety signals on AEB071 in patients during the 24 months follow-up period.
Conditions
Interventions
Product Name: AEB071
Product Code: AEB071A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not established
CAS Number: 425637-18-9
Current Sponsor code: AEB071 drug substance, mono acetate
Oth
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •The patient has given written informed consent to participate in the extension study. •The patient has been maintained on AEB071/myfortic® or tacrolimus/myfortic®, consistent with their original randomization, 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). 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. •Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect the exploratory long term safety and renal safety by measuring GFR (modification of diet in renal disease, MDRD) beyond 12 months for AEB071 in combination with myfortic® in a CNI free regimen, in comparison to a standard CNI based regimen. ;Secondary Objective: Collection of exploratory efficacy data. The key efficacy parameter is the incidence over 36 months of the composite endpoint of biopsy proven acute rejection = 1A, graft loss, death, or loss to follow-up between the two study arms. ;Primary end point(s): The following efficacy endpoints will be examined: •BPAR = 1A, graft loss, death, or loss to follow-up. •BPAR = 1A, graft loss, death, or loss. •BPAR = 1A. •Death or graft loss. •Death. •Graft loss. •Treated acute rejections. •Treated acute rejections, graft loss, death, or loss to follow-up. Safety variables to be assessed include discontinuations from study, discontinuations from treatment, renal safety, AEs, SAEs, notable events, laboratory tests, vital signs, ECGs, semi quantitative CNI-specific signs and symptoms, and dermatological assessments. | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed