renal transplantation MedDRA version: 14.1 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Certican 0,5 mg Tabletten
Product Name: Certican
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Conce
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged > 65 years, receiving the first kidney from a donor aged > 65 years in the Eurotransplant Senior Program 2. Recipients of de novo cadaveric kidney transplants 3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: 1. Multi-organ recipients (e.g., kidney and pancreas) 2. Patients receiving a kidney from a non-heart beating donor 3. Patients who are recipients of A-B-0 incompatible transplants 4. Patients with a historical or current peak PRA of > 25% (current = 3 months) 5. Patients with already existing antibodies against the HLA-type of the receiving transplant 6. Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, cyclosporine A, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations (e.g. lactose) 7. Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1) 8. Patients with thrombocytopenia (platelets 3 times UNL) 12. Females at randomization who will be considered post-menopausal according to the following definition: = 12 months of natural (spontaneous) amenorrhea or = 12 month post surgical bilateral oophorectomy or hysterectomized women over or equal to 65 years of age 13. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study 14. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin 15. Evidence of drug or alcohol abuse 16. Patients receiving drugs known to strongly interact with CsA and/or everolimus according to the list provided in Appendix 3 to this protocol should be excluded, if in the opinion of the investigator this drug interaction interferes with the objectives of the study, namely a clinical meaningful potentiation of renal dysfunction and/or maintenance of adequate immunosuppressive drug levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to exploratively examine superiority of a treatment regimen with Certican with respect to the renal function at 6 months after renal transplantation (Tx) assessed by glomerular filtration rate (GFR) – Cockcroft-Gault method - as compared to the standard regimen in de novo senior renal transplant recipients;Secondary Objective: • to assess renal function by GFR – MDRD and Nankivell method – at Month 6 post Tx • to assess renal function by serum creatinine at Month 6 post Tx • to assess efficacy (biopsy proven acute rejection, graft loss, death) at Month 6 • to asses occurrence of treatment failures up to or at Month 6, while treatment failure is defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity, or conversion to another regimen (at least one condition must be present) • to assess evolution of renal function (creatinine slope) between Week 7 (randomization) and Month 6 • to assess CD25 saturation on lymphocytes • to assess safety and tolerability at Month 6: - AE/SAE - incidence of infections (CMV, BK virus) - tumor incidence - cardiovascular risk - occurrence of proteinuria - NODM ;Primary end point(s): The primary objective of this study is to exploratively examine superior renal function under the Certican®-based regimen as compared to the control regimen. The primary variable for assessment of renal function is the glomerular filtration rate (GFR) at Month 6, as assessed by the Cockcroft-Gault method. | — |
Countries
Germany
Outcome results
None listed