Prospective Randomized Study of a Steroid Free, Low Dose Tacrolimus with Everolimus Regimen in Kidney Transplant.
Northwestern University, Chicago, IL
University of Virginia, Chicago, IL.
Meeting: 2016 American Transplant Congress
Abstract number: B110
Keywords: Calcineurin, Immunosuppression
Session Information
Session Name: Poster Session B: Drug Minimization
Session Type: Poster Session
Date: Sunday, June 12, 2016
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Calcineurin inhibitors (CNI) serve as the cornerstone of immunosuppression (IS) after kidney transplant. However chronic CNI nephrotoxicity has been implicated in allograft dysfunction. We hypothesize that lower CNI exposure combined with low dose Everolimus may result in better graft outcomes.
Methods: We conducted a prospective study in 40 adult kidney transplant recipients randomized to steroid free IS with low dose Tacrolimus (Tac) and Everolimus (Ev) or standard dose Tac and Mycophenolate Mofetil (MMF) after Alemtuzumab induction. Everolimus levels were maintained between 3-8 ng/ml. Follow up included protocol kidney biopsy at 3 and 12 months post-transplant. Primary outcomes were rejection free graft survival and estimated GFR (eGFR).
Results: Baseline characteristics (demographics, HLA match and time on dialysis) were statistically similar between the two groups. Mean follow up was 14±4 and 17±5 months and mean Tac levels were 4.5±1.9 and 6.4±1.5 ng/ml in the Tac+Ev and Tac+MMF group respectively
|
Results |
Tac + Ev |
Tac +MMF |
p value |
|
|
n = 20 |
n = 20 |
|
|
Mean Follow up (months)* |
14±4 |
17±5 |
0.02 |
| Mean Tac levels (ng/ml)* | 4.5±1.9 | 6.4±1.5 | 0.03 |
| Patient Survival (%) | 100 | 100 | 1 |
|
Graft Survival (%) |
100 |
100 |
1 |
|
Rejection |
0 |
3 |
0.23 |
| eGFR at 12 months (ml/min)* | 72±21 | 65±20 | 0.3 |
|
* mean ± SD |
|||
. Rejection free graft survival was greater in the Tac+Ev group
. However patient survival, overall graft survival and eGFR were similar between groups. Similarly incidence of adverse events, including proteinuria were similar.
Conclusion: Rejection free graft survival was greater in patients immunosuppressed with low dose Tac+ Ev compared to standard dose Tac+ MMF, possibly related to lower calcineurin exposure combined with an effect of T-regulatory cells. Further studies with longer clinical follow up and evaluating impact on T regulatory cells are warranted.
CITATION INFORMATION: Shetty A, Traitanon O, Ansari M, Mathew J, Leventhal J, Mas V, Gallon L. Prospective Randomized Study of a Steroid Free, Low Dose Tacrolimus with Everolimus Regimen in Kidney Transplant. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Shetty A, Traitanon O, Ansari M, Mathew J, Leventhal J, Mas V, Gallon L. Prospective Randomized Study of a Steroid Free, Low Dose Tacrolimus with Everolimus Regimen in Kidney Transplant. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/prospective-randomized-study-of-a-steroid-free-low-dose-tacrolimus-with-everolimus-regimen-in-kidney-transplant/. Accessed May 31, 2025.« Back to 2016 American Transplant Congress