de novo heart transplantation
Conditions
Interventions
Product Name: Certican 0.25mg
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization. • Patients who have given written informed consent to participate in the study. • Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. Females are eligible if they are postmenopausal for at least 24 months past last natural menses. Study medication should not be administered until a negative pregnancy test report is obtained. Two or more acceptable methods of contraception should be started 1 month prior to beginning study drug unless abstinence is the chosen method, during therapy, and for 3 months after stopping the study. Abstinence is an allowed contraceptive method if in the judgment of the investigatorthe patient is reliably abstaining. Celibate members of religious orders (like nuns, priests, etc...) will be considered in consultation with the local Novartis Medical Advisor on a case by case basis. Although there may be local/ country specific differences, acceptable forms of birth control include any two or more of the following methods: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), IUD and barrier methods (male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 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: • Calculated creatinine clearance 6 hours. • Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4. (See appendix 4). • Patients who are unable to take oral medication by mouth (short- term NG administration allowed no longer than Day 5). • Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer. • Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study. • Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use at least 2 effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if comparable rates of the composite efficacy failure (biopsy-proven acute rejection of ISHLT grade = 3A, acute rejection episodes associated with hemodynamic compromise, graft loss/retransplant, death, or loss to follow-up) are achieved in cohorts of de novo heart recipients treated with Certican-reduced Neoral versus MMF-Neoral standard dose at 12 months after initial dose of study medication ;Secondary Objective: Main Secondary Objectives: • To assess incidence of graft loss/re-transplant, defined as a 0.5mm increase in maximum initial thickness in at least one matched slice of an automated pullback sequence between baseline and month 12 in patients receiving Certican and those receiving MMF. • To demonstrate that similar renal function assessed by calculated GFR by MDRD formula [Coresh et. al. (2003)] is achieved in the Certican treatment arm compared to the MMF treatment arm within 12 months of initial dose of study medication. For other objectives please refer to protocol.;Primary end point(s): The primary objective of the study is to show that either one of the Certican arms is non-inferior to the MMF treatment arm, with respect to primary efficacy failure at 12 months. The primary variable is the incidence of composite efficacy failure event, including biopsyproven acute rejection episodes (BPAR) of ISHLT grade =3A, acute rejection episodes associated with hemodynamic compromise, graft loss/re-transplant, death or loss to follow-up within 12 months of initial dose of study medication. A lost to follow-up patient for the primary efficacy endpoint is defined as one who did not experience BPAR=3A, acute rejection episodes associated with hemodynamic compromise, graft loss/re-transplant, did not die and whose last contact day is < Day 316, which is the lower limit of the 12 month visit window. | — |
Countries
Austria, Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed