Kidney transplantation MedDRA version: 17.0 Level: LLT Classification code 10054990 Term: Immunodeficiency secondary to organ transplantation System Organ Class: 100000004870
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female renal allograft recipients at least 18 years old 2. Patient who has received a primary or secondary kidney transplant from a deceased or living unrelated-/related donor 3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained 4. Recipient of a kidney allograft with a cold ischemia time (CIT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney 2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation) 3. Patients receiving a kidney from a non-heart beating donor 4. Patients who are recipients of A-B-0 incompatible transplants 5. Patients with a current Panel Reactive Antibody (PRA) level of > 20% (PRA levels within 4 months prior to enrollment) or patients with a positive Luminex test for any antigen of the donor 6. Patients with already existing antibodies against the HLA-type of the receiving transplant (in the knowledge of the investigator at the time point of transplantation) 7. Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients 8. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 9. Patients with thrombocytopenia (platelets 5 mIU/ml)) o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy **examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe: ? Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9) ? Vaginal ring (PI=0.65 uncorr.; 0.4 corr.) ? Contraceptive patch (PI= 0.72 uncorr.; 0.9 corr.) ? Estrogen-free ovulation inhibitors (PI=0.14) ? Progestin-containing contraceptives (PI=0-0.08) ? Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.) ? Intra-uterine progestine device (PI=0.16) Highly effective contraception methods include: ? Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard group at month 12 post-transplantation in renal transplant patients.;Secondary Objective: • To assess renal function by means of glomerular filtration rate at Month 12 post-transplantation • To assess the incidence of individual endpoints BPAR, graft loss and death at Month 12 post-transplantation • To assess the incidence and severity of viral infections • To assess the incidence and duration of Delayed Graft Function • To assess the incidence of Slow Graft Function defined as serum creatinine > 3,0 mg/dl at day 5 • To assess the incidence of wound healing complications related to the surgery • To assess the duration of healing • To compare the overall safety and tolerability at Month 12 post-transplantation ;Primary end point(s): The primary efficacy variable of this trial is the renal function at Visit 7/Month 12 after randomization as assessed by estimated glomerular filtration rate (eGFR) based on recalculated values according to the Nankivell formula.;Timepoint(s) of evaluation of this end point: at 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary efficacy variables will be analyzed in an explorative manner for the full analysis set (FAS): • Key secondary objective is to assess the incidence of treatment failure (combinded endpoint of BPAR, graft loss or death). Additional secondary objectives are: • To assess the incidence of individual components of the combined efficacy endpoint, that is BPAR, graft loss and death at Month 12 post-transplantation. • To assess renal function by cGFR according to the CKD-EPI, Cockcroft-Gault and MDRD methods, respectively. • To assess the incidence and duration of Delayed Graft Function. • To assess the incidence of Slow Graft Funtion. • To assess safety and tolerability during the study, especially the incidence and severity of viral infections (CMV, BKV), the incidence of wound healing complications, and the incidence of Left Ventricular Hypertrophy (LVH) . ;Timepoint(s) of evaluation of this end point: at 12 month | — |
Countries
France, Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed