de novo heart transplant patients MedDRA version: 9.1 Level: HLGT Classification code 10028593 Term: Myocardial disorders
Conditions
Interventions
Trade Name: CERTICAN
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: CERTICAN
Pharmace
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: To be checked at screening: - male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation; - patients who have given written informed consent to participate in the study. To be checked at randomization: - GFR (by MDRD) ≥ 40 mL/min/1.73m2. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be checked at screening: - patients who are recipients of multiple solid organ transplants; - known hypersensitivity to rapamycin derivatives; - Known intolerance to cyclosporine or statins - patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive; - presence of Donor/Recipient serological mismatch for Hepatitis B or C; - recipients of organ from donors positive for Hepatitis B-surface antigen; - Panel Reactive Antibodies (cytotoxicity method) > 30%; - patients who are taking other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; - females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. To be checked at randomization - platelet count 6 hours; - patients unable to take oral medication; - patients who need treatment with drugs that are strong inducers or inhibitors of cytochrome P450 3A4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the 6-month cumulative incidence of the safety composite endpoint of wound healing complications related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as GFR ≤ 30/ml/min/1.73m2 , between the delayed EVE arm and the immediate EVE.;Secondary Objective: Secondary objectives of the study aim to compare study groups with respect to: - incidence of the composite efficacy endpoint including biopsy-proven rejection ≥2R, rejection with hemodynamic compromise, graft loss, and death; - separate incidences of wound healing delay, pericardial/pleural effusions and acute renal insufficiency (defined by a GFR ≤ 30ml/min/1.73m2); - separate incidences of biopsy-proven acute rejection ≥ 2R, rejection with hemodynamic compromise, graft loss, and death; - proportion of patients with LDL ≥ 100ng/ml at 1, 3 and 6 months; - overall and separate incidence of adverse events, serious adverse events and adverse events leading to treatment discontinuations; - incidence of CMV infection, assayed either by pp65 antigenemia or DNAemia, and of CMV syndrome/disease;Primary end point(s): The primary study outcome measure will be evaluation of the composite safety endpoint including wound healing complications, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as GFR ≤ 30/ml/min/1.73m2 | — |
Countries
Italy
Outcome results
None listed