de novo kidney transplant patients MedDRA version: 9.1 Level: LLT Classification code 10023439 Term: Kidney transplant rejection
Conditions
Interventions
Trade Name: Certican Tabletten
Product Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Concentration unit: mg milligram(
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged 18 – 70 years 2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants 3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline visit 1, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility 4. 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) 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: 1. More than one previous renal transplantation 2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney 3. Patients receiving a kidney from a non-heart beating donor 4. Donor age: 70 years 5. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation) 6. Patients who are recipients of A-B-O incompatible transplants 7. Patients with a historical or current peak PRA of > 25% (current = 3 months) 8. Patients with already existing antibodies against the HLA-type of the receiving transplant 9. 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) 10. Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1) 11. Patients with thrombocytopenia (platelets 3 times UNL) 16. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception 17. 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 18. Evidence of drug or alcohol abuse 19. 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 demonstrate superiority of a CNI-free regimen respect to the renal function at Month 12 post Tx assessed by glomerular filtration rate – Nankivell method – as compared to the standard regimen in de novo kidney transplant patients.;Primary end point(s): The primary aim of this study is to demonstrate superior renal function under the CNI-free regimen as compared to the Standard regimen. The primary variable for assessment of renal function is the glomerular filtration rate (GFR) at Month 12, as assessed by the Nankivell method.;Secondary Objective: • to assess renal function by glomerular filtration rate at Month 12 post Tx of the CNI-low dose regimen compared to the standard regimen • to assess renal function by glomerular filtration rate at Month 12 post Tx • to assess renal function by serum creatinine at month 12 post Tx • to assess efficacy at Month 6 and 12 • to asses occurrence of treatment failures up to or at Month 12 • to assess evolution of renal function between Month 3 and 12 • to assess safety and tolerability at Month 12: - AE/SAE - incidence of infections (with special emphasis on CMV) - tumor incidence - cardiovascular risk (changes in Framingham score) - occurrence of proteinuria • to assess efficacy, safety and tolerability at Follow-up visits at month 18, 24, 36, 48, and 60 | — |
Countries
Germany
Outcome results
None listed