Prospective Study of a Steroid Free, Low Dose Tacrolimus and Everolimus Combination Regimen in Kidney Transplant

A. Shetty,¹ J. Leventhal,¹ O. Traitanon,¹ A. Alvarado,¹ V. Mas,² J. Mathew,¹ E. Tantisattamo,¹ L. Gallon.¹

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.

Results
	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

* results expressed as mean ± standard deviation. ** Other infections included bacteremia, clostridium difficile colitis, abdominal abscess and herpes zosterConclusion: Graft survival and function were similar in patients treated with low dose Tac+ Everolimus compared to standard dose Tac+ MMF. Further studies evaluating impact of T regulatory cells and longer clinical follow up will be conducted

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 May 18, 2025.

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