Prospective Study of a Steroid Free, Low Dose Tacrolimus and Everolimus Combination Regimen in Kidney Transplant
1Nephrology/Comprehensive Transplant, Northwestern University, Chicago
2Surgery, Virginia Commonwealth University, Richmond.
Meeting: 2015 American Transplant Congress
Abstract number: D133
Keywords: Calcineurin, Graft survival, Immunosuppression
Session Information
Session Name: Poster Session D: Kidney Immunosuppression: Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Calcineurin(CNI) based therapy is the cornerstone of immunosuppresion(IS) after kidney transplant. However chronic nephrotoxicity from CNI as been implicated in post-transplant renal dysfunction. We hypothesized that lowering CNI exposure in combination with low dose Everolimus may result in better graft outcomes, possibly related to an effect on T-regulatory cells.
Methods: We conducted a prospective study in adult living donor kidney transplant recipients randomized to steroid free IS with low dose Tacrolimus(Tac) and Everolimus (n=19) or standard dose Tac and Mycophenolate Mofetil (n=20). All patients received Alemtuzumab induction. Everolimus levels were maintained between 3-8 ng/ml. In the standard IS group Tac levels were maintained between 8-10 ng/ml upto 2 months, 6-8 ng/ml from 2- 6 months and 4-8 ng/ml after 6 months post-transplant. Tac levels in the low dose group were maintained between 4-7 ng/ml upto 2 months, 3-5 ng/ml from 3-6 months and 2-5 ng/ml after 6 months post-transplant, reflecting a 50% lower dose than standard IS. Follow up included protocol kidney biopsy at 3 and 12 months post-transplant. Primary outcomes were graft survival, rejection free graft survival and estimated GFR.
Results: Mean age at transplant was 47±16 and 50±14 years in the Tac+Everolimus and Tac+MMF group respectively (p=0.42). Other baseline characteristics including demographics, HLA match and time on dialysis were statistically similar. There was no difference in primary outcomes or adverse events between the two groups.
Tac+Ev | Tac+MMF | p value | |
n = 19 | n = 20 | ||
Mean Follow up (months)* | 13 ± 4 | 14 ± 4 | 0.22 |
Graft Survival (percent) | 100 | 100 | 1.00 |
Graft function (eGFR in ml/min/1.73m2)* | 70 ± 23 | 66 ± 22 | 0.55 |
Rejection episodes | 0 | 3 | 0.23 |
Development of Denovo DSA without rejection | 1 | 1 | 1.00 |
Proteinuria > 1g/day | 2 | 0 | 0.49 |
Adverse Events | |||
Hypertriglyceridemia | 3 | 1 | 0.34 |
BK nephropathy | 0 | 1 | 1.00 |
Neutropenia | 0 | 1 | 1.00 |
Other Infections** | 5 | 3 | 0.45 |
To cite this abstract in AMA style:
Shetty A, Leventhal J, Traitanon O, Alvarado A, Mas V, Mathew J, Tantisattamo E, Gallon L. Prospective Study of a Steroid Free, Low Dose Tacrolimus and Everolimus Combination Regimen in Kidney Transplant [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/prospective-study-of-a-steroid-free-low-dose-tacrolimus-and-everolimus-combination-regimen-in-kidney-transplant/. Accessed October 15, 2024.« Back to 2015 American Transplant Congress