Prevention of the rejection in adult patients receiving a de-novo renal transplant in combination with Neoral and corticosteroids MedDRA version: 14.1 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration number: .75-
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mycophenol
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria ? Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation, females not pregnant or lactating ? Recipients of primary cadaveric, living unrelated or non HLA identical living related donor ? Patients who have given written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: 0 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: Exclusion criteria ? Cold ischemia time >40 hours, non-heartbeating donor , donor age >65 ? Patients with platelet count 350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable ? Patients who have an abnormal liver profile such as ALT, AST, Alk Phos or total bilirubin >3 times the ULN ? Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450, patients treated with terfenadine, astemizole, cisapride or lovastatin ? Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization ? Patients with a 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months.;Secondary Objective: Main secondary objectives Efficacy: To compare the incidence of graft loss, death or loss to follow up (composite) between Certican and Myfortic treatment arms at 12 months post-transplantation. Safety: To compare renal function (calculated GFR using the MDRD formula (Coresh et. al. 2003) between Certican treatment arms and the Myfortic treatment arm at 12 months post-transplantation. Population: The study population will consist of a representative group of male and female transplant recipients 18-70 years of age undergoing primary renal transplantation. Eight hundred and twenty-five patients are planned to be enrolled.;Primary end point(s): Primary objective: To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months. | — |
Countries
Italy, Sweden, United Kingdom
Outcome results
None listed