Phase 3
Completed N=114
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Organ Transplantation, Renal Transplantation
Source: ClinicalTrials.gov NCT00154284 ↗
Enrolled (actual)
114
Serious AEs
26.3%
Results posted
Mar 2011
Primary outcomePrimary: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) — 68.5; 69.2; 63.6; 68.3 mL/min per 1.73 m^2
Summary
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) |
68.5; 69.2; 63.6; 68.3 | — |
| SECONDARY Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up |
10; 10; 0; 0; 0; 0 | — |
| SECONDARY Serum Creatinine at Month 6 and 12 |
120.1; 139.1; 123.0; 135.6 | — |
| SECONDARY Calculated Creatinine Clearance at 6 Month and 12 Month |
72.9; 63.6; 72.3; 65.6 | — |
Eligibility Criteria
Inclusion Criteria
- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
- Renal cold ischemic time < 36 hours.
- Age of donor < 65 years.
Exclusion Criteria
- Patients who have received an investigational drug within 4 weeks of baseline period.
- Patients who are recipients of multiple organ transplants, including any organ other than kidney.
- Recipients of non-heart beating donor organs.
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00154284). 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.