Recipients of a de novo kidney transplant. MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Trade Name: CERTICAN
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .75-
Trade Name: SANDIMMUN NEORAL
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females, >18 years of age at transplant; Recipients of 1st or 2nd single kidney transplant; Donor age >14 years; Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline (Visit 2), and are required to practice an approved method of birth control for the duration of the study and for a period of 2 months following discontinuation of study medication; 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: recipients of kidney-pancreas transplant, double kidney or any other transplant; recipients of a 2nd kidney transplant who lost the 1st for immunological reasons; Focal segmental glomerulosclerosis (FSGS), primary oxaluria or other diseases (as cause of end stage renal failure - ESRF) at high risk of rapid recurrence or requiring continuous corticosteroid treatment; Recipients of A-B-O incompatible transplants; Historical or current peak PRA of > 25% (current = 3 months); Patients with already existing antibodies against the donor; Thrombocytopenia (platelets 3 times UNL); Evidence of drug or alcohol abuse; Body mass index (BMI) > 35;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The purpose of this study is to compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine given twice a day and continuous steroids. Regimens A and B will be compared for non-inferiority with the control group (group C) using as main endpoint the treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost to follow-up between randomization and Month 12.;Main Objective: The primary objective of the study is to demonstrate, in renal transplant patients receiving everolimus and cyclosporin, the non-inferiority of one of the two following regimens: once-a-day regimen (Group A) OR steroid withdrawal regimen (Group B) in comparison with the standard twice-a-day regimen (Group C), using the treatment failure rate (composite endpoint of biopsy-proven acute rejection, graft loss, death or lost to follow-up) between randomization and Month 12 as primary endpoint.;Secondary Objective: .to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the once-a-day group (Group A) and in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non inferiority. To compare between groups the biopsy-proven acute rejection (BPAR) rate after randomization; To compare between groups the death censored graft survival, raft survival and patient survival after randomization; To compare the 6 and 12-month renal function between groups, using the estimated creatinine clearance (Cockcroft and Gault and MDRD 4-variable equation), the GFR (Nankivell) and serum creatinine; To estimate the percentage of patients who are compliant to the randomized treatment in the three groups, by month 12; | — |
Countries
Italy
Outcome results
None listed