de novo transplant recipients of Expanded Criteria Donor (ECD) kidneys MedDRA version: 12.1 Level: PT Classification code 10023439 Term: Kidney transplant rejection
Conditions
Interventions
Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mycophenolate sodium
CAS Number: 37415-62-6
Other descriptive name: M
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females between 18 and 75 years old inclusive 2. Recipients of first or second cadaveric kidney transplant from Expanded Criteria Donor (ECD), with ECD being defined as Brain-dead donor > 60 years old OR Donor age > 50 years old with two of the following criteria: - History of hypertension - Terminal serum creatinine = 1.5 mg/dL - Death resulting from cerebrovascular accident 3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Transplantation 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. Multi-organ recipients (e.g. kidney and pancreas, dual kidneys) 2. Cold ischemia time > 30 hours 3. Organ donation after Cardiac Death (DCD) 4. Patients with a current Panel Reactive Antibodies (PRA) > 20 % or with historical peak PRA > 50% 5. Patients who lost a first graft due to immunological reasons within the first year post-transplantation 6. Patients who received ATG as induction therapy 7. Patients who are known to have chronic active Hepatitis C, who are HIV or Hepatitis B surface antigen (HBsAg) positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of the conversion from a CNI to everolimus starting between Week 12 and 16 compared to a CNI-based regimen, both given in combination with Myfortic and corticosteroids, in terms of renal function assessed by estimated Glomerular Filtration Rate (eGFR) by Cockcroft-Gault formula in de novo transplant recipients of ECD kidneys at 12 months post-transplantation.;Secondary Objective: The key secondary objective is to demonstrate non-inferiority of treatment failure (defined as treated biopsy-proven acute rejection [BPAR], graft loss [GL] or death) between the two arms at 12 months post-transplantation. Additional main secondary objectives will assess: rates of BPAR between randomization and Months 6 and 12 posttransplantation; renal function by means of serum creatinine and eGFR at Months 6, 9 and 24 post-transplant; incidence of proteinuria = 0.5 g/day, 0.6 - 1.0 g/day, 1.1 - 3.0 g/day and > 3.0 g/day at various time points; compare the overall safety and tolerability at Month 12 post-transplant; incidence of BK viruria and viremia at Months 3 (or conversion), 6 and 12 post-transplant;Primary end point(s): renal function assessed by estimated Glomerular Filtration Rate (eGFR) by Cockcroft-Gault formula | — |
Countries
Czech Republic, Latvia, Spain
Outcome results
None listed