Phase 3
N=285
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Transplantation Infection
Bottom Line
View on ClinicalTrials.gov: NCT01276457 ↗Enrolled (actual)
285
Serious AEs
61.4%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Biopsy-proven Acute Rejection — 21; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Everolimus 0.25 and 0.75 mg tablets (Drug); Cyclosporine very low dose (150-300 ng/mL) microemulsion (Drug); Cyclosporine low dose (350-500 ng/mL) microemulsion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biopsy-proven Acute Rejection |
21; 21 | — |
| PRIMARY Renal Function Assessed by Creatinine Clearance |
61.26; 62.50; 60.90; 62.80; 61.92; 63.76 | — |
| SECONDARY Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft |
2; 3; 6; 15; 8; 18 | — |
| SECONDARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths |
142; 143; 95; 101; 58; 53 | — |
Summary
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.
Eligibility Criteria
Inclusion Criteria
- Patients with functioning graft who had completed the 6-month treatment period of core study
- Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
- Patients who signed the informed consent of the present study extension
Exclusion Criteria
- Women who were pregnant, lactating or who wished to became pregnant.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT01276457). 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.