Phase 3
N=721
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Graft Rejection
Bottom Line
View on ClinicalTrials.gov: NCT00300274 ↗Enrolled (actual)
721
Serious AEs
69.5%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants With Composite Efficacy Failure at 12 Months — 35.1; 35.1; 33.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- everolimus (Drug); mycophenolate mofetil (Drug); cyclosporine (Drug); corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Efficacy Failure at 12 Months |
35.1; 35.1; 33.6 | — |
| SECONDARY Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months |
11.7; 11.9; 8.9 | — |
| SECONDARY Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months |
59.21; 59.78; 64.37 | — |
| SECONDARY Change From Baseline in the Average Maximum Intimal Thickness at Month 12 |
0.03; 0.04; 0.07 | — |
| SECONDARY Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 |
12.5; 21.6; 26.7 | — |
| SECONDARY Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 |
3.9; 3.0; 2.6; 22.3; 25.6; 24.7 | — |
| SECONDARY Percentage of Participants With Composite Efficacy Failure at 24 Months |
39.4; 41.1; 41.3 | — |
| SECONDARY Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months |
15.2; 16.1; 15.1 | — |
| SECONDARY Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months |
59.50; 61.84; 64.52 | — |
| SECONDARY Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 |
4.3; 3.6; 5.2; 24.1; 28.6; 27.3 | — |
Summary
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
Eligibility Criteria
Inclusion Criteria
- Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
- The graft must be functional at time of randomization.
Exclusion Criteria
- Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants.
- Patients who are recipients of ABO incompatible transplants.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00300274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.