drugset / Trial / NCT01410448
Everolimus in de Novo Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.
Timeline
- Start
- 2011-11
- Primary completion
- 2015-12
- Completion
- 2015-12
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Immediate Everolimus (IE) vs Delayed Everolimus (DE); p = 0.0921; Regression, Logistic NCT01410448 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | — | Oral |
| Subject | Everolimus | Small molecule | 0.75 mg | Oral |
| Subject | Mycophenolate Sodium | Unknown | 720 mg | Oral |
Indications
No indication recorded.