Phase 3
Completed N=833
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT00251004 ↗Enrolled (actual)
833
Serious AEs
65.1%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis — 75; 60; 70; 8 Participants
Summary
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis |
75; 60; 70; 8; 9; 6 | — |
| PRIMARY Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints |
27.1; 21.5; 25.3 | 0.014 sig |
| SECONDARY Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation |
11.6; 9.7; 9.4 | 0.001 sig |
| SECONDARY Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula |
54.66; 51.41; 52.24 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female patients of any race between 18 to 70 years old (inclusive)
- Patients who gave written informed consent to participate in the study
Exclusion Criteria
- Recipients of multi-organ transplantation
- Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
- Graft cold ischemia time greater than 40 hours.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00251004). 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. Informational only — not medical advice.