Phase 4
N=139
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
Renal Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00154297 ↗Enrolled (actual)
139
Serious AEs
73.4%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months — 36; 47; 16; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (RAD001) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months |
36; 47; 16; 18; 14; 15 | — |
| SECONDARY Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. |
39; 48; 16; 18; 17; 22 | — |
| SECONDARY Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. |
42; 49; 16; 18; 22; 25 | — |
| SECONDARY Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period |
16; 24 | — |
| SECONDARY Duration of Dialysis |
11.9; 7.8 | — |
| SECONDARY Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period |
28; 32; 26; 28; 2; 6 | — |
Summary
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.
Eligibility Criteria
Inclusion Criteria
- Recipients of cadaveric kidney transplants
- Patients at risk of DGF defined as one or more of the following:
- Donor age > 55 years
- Cold ischemic time (CIT) ≥ 24 hours but 32 kg/m2
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00154297). 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.