Phase 3
N=383
Everolimus in de Novo Kidney Transplant Recipients
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01410448 ↗Enrolled (actual)
383
Serious AEs
35.0%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants Without Wound Healing Complications - Worst-case Scenario — 68.39; 61.58 Percentage of participants — p=0.0921
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Everolimus (Drug); Mycophenolate sodium (Drug); Cyclosporine (Drug); Steroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Wound Healing Complications - Worst-case Scenario |
65.80; 59.47 | — |
| SECONDARY Percentage of Participants Without Wound Healing Complications - Worst-case Scenario |
65.80; 59.47 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario |
11.40; 21.05 | — |
| SECONDARY Patient Survival Rate: Percentage of Deaths - Worst-case Scenario |
6.22; 18.42 | — |
| SECONDARY Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario |
6.74; 18.42 | — |
| SECONDARY Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario |
6.74; 18.42; 7.25; 19.47 | — |
| SECONDARY Percentage of Participants With BPAR - Worst-case Scenario |
11.40; 21.05; 15.54; 24.74 | — |
| SECONDARY Percentage of Participants With Delayed Graft Function (DGF) - |
23.83; 31.58 | — |
| SECONDARY Duration of DGF |
8.50; 5.50 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT |
38.64; 39.13 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT |
41.26; 41.56 | — |
| SECONDARY Change From Baseline in Serum Creatinine - ITT |
-4.79; -5.13 | — |
| SECONDARY Change From Baseline in Serum Creatinine - Modified ITT |
-4.96; -5.22 | — |
| SECONDARY Percentage of Participants With Proteinuria |
4.15; 4.21; 68.91; 68.42; 26.94; 27.37 | — |
| SECONDARY Percentage of Participants With Acute Rejection (AR) |
12.44; 10.53 | — |
| SECONDARY Percentage of Participants With a New Onset of Malignancy |
0; 0.68 | — |
| SECONDARY Percentage of Participants With a New Onset of Diabetes |
3.14; 4.05 | — |
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.
Eligibility Criteria
Key Inclusion criteria
- Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure;
- Men or women ≥18 years at transplant;
- Recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor > 14 years;
Key Exclusion criteria
- Patients who are recipients of multiple organs transplant, including two kidneys;
- Historical or current peak PRA > 50%. Patients with already existing antibodies against the donor;
- Thrombocytopenia (platelets 30 Kg/m2;
Data sourced from ClinicalTrials.gov (NCT01410448). 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.