Extended-Release Tacrolimus Plus Everolimus vs Extended-Release Tacrolimus Plus Micophenolate Mofetil in Primary Deceased Donor Kidney Transplant Recipients: 1-Year Results of an Open Label, Randomized Phase 2 Clinical Trial
Surgery - Renal Transplantation, Catholic University, Rome, Italy
Meeting: 2013 American Transplant Congress
Abstract number: B950
Purpose. Aim of this randomized phase 2 trial in kidney transplantation was to compare an immunosuppressive regimen based on the association of low-dose ER-tacrolimus and everolimus to a standard dose ER-tacrolimus and MMF regimen. Results at 1 year of follow up are presented.
Methods. Fortytwo primary deceased donor kidney transplant recipients were randomly assigned before transplantation to receive ER-tacrolimus plus everolimus (EVE group: 21 patients) or ER-tacrolimus plus mycophenolate mofetil (MMF group: 21 patients). As induction therapy all patients received a combination of basiliximab (20 mg IV on day 0 and day 4), thymoglobulin (50 mg/day IV from day 0 to day 3) and steroids (methylprednisolone 500 mg IV on day 0 and 125 mg IV on day 1). Assigned study medications were orally administered once daily starting on p.o. day 4. Six months after transplantation steroids were selectively withdrawn in patients with no acute rejection episodes, serum creatinine < 2 mg/dL and proteinuria < 300 mg/L/24 h.
Results. Demographics were similar between groups. Efficacy and safety parameters after 1 year of follow up are summarized in table 1.
| MMF | EVE | p | |
| Patient survival (%) | 100 | 95 | ns |
| Gaft survival (%) | 100 | 95 | ns |
| BPAR (%) | 5 | 0 | ns |
| DSA + (%) | 10 | 15 | ns |
| MDRD (mL/min/1.73m²) | 51±17 | 52±21 | ns |
| Proteinuria 24h (mg/L) | 0.1±0.2 | 0.2±0.2 | ns |
| Hemoglobin (g/dL) | 12.7±1.5 | 13±1.7 | ns |
| WBC count (cell x 10^9/L) | 6.9±2.5 | 6±1.5 | ns |
| Platelet count (cell x 10^9/L) | 290±160 | 218±72 | ns |
| Total cholesterol (mg/dL) | 208±52 | 212±39 | ns |
| Triglycerides (mg/dL) | 160±109 | 178±112 | ns |
| Dislipidemia on treatment (%) | 35 | 40 | ns |
| Hypertension on treatment (%) | 76 | 85 | ns |
| NODAT (%) | 5 | 11 | ns |
| CMV infection (%) | 38 | 15 | ns |
| CMV disease (%) | 0 | 0 | ns |
| PVAN (%) | 0 | 0 | ns |
| UTI (%) | 43 | 40 | ns |
| PTLD (%) | 0 | 0 | ns |
| Wound dehiscence (%) | 0 | 0 | ns |
| ER-tacrolimus C0 (ng/mL) | 6.7±1.5 | 3.9±1.8 | <0.01 |
| Steroid withdrawal (%) | 43 | 45 | ns |
| Drop out (%) To cite this abstract in AMA style: Favi E, Silvestrini N, Pedroso J, Salerno M, Spagnoletti G, Bianchi V, Romagnoli J, Citterio F. Extended-Release Tacrolimus Plus Everolimus vs Extended-Release Tacrolimus Plus Micophenolate Mofetil in Primary Deceased Donor Kidney Transplant Recipients: 1-Year Results of an Open Label, Randomized Phase 2 Clinical Trial [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/extended-release-tacrolimus-plus-everolimus-vs-extended-release-tacrolimus-plus-micophenolate-mofetil-in-primary-deceased-donor-kidney-transplant-recipients-1-year-results-of-an-open-label-randomize/. Accessed March 31, 2020.« Back to 2013 American Transplant Congress |