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Early Steroid Withdrawal and Calcineurin Inhibitor Minimization Protocols for Maintenance Immunosuppression: A Single Center 10-Year Experience

R. Lopez-Soler,1 L. Park,3 J. Martinolich,2 D. Conti.1

1Transplant Surgery, Albany Medical Center, Albany, NY
2Surgery, Albany Medical Center, Albany, NY
3Albany School of Medicine, Albany, NY.

Meeting: 2015 American Transplant Congress

Abstract number: D114

Keywords: Graft survival, Kidney transplantation, Outcome, Post-transplant diabetes

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

BACKGROUND:

Long term use of steroids results in predictable secondary effects that can lead to increased morbidity and mortality. Additionally, long term high levels of Calcineurin Inhibitors (CNI) have produced excellent post-transplant outcomes, but at a cost of additional morbidities. In this study, we present 10 years' worth of data of maintenance immunosuppression consisting of Mycophenolate, Sirolimus, and Low-level Tacrolimus.

METHODS:

From 2003 to 2010, 379 kidney transplant recipients (66% deceased donors) discontinued prednisone on post-operative day 6. Induction therapy consisted of Thymoglobulin and a rapid steroid taper. Maintenance therapy consisted of Mycophenolate, Sirolimus, and Tacrolimus. Mycophenolate therapy was initiated on post-op day 0, while both Tacrolimus and Sirolimus were started between post-op day 4-6 concomitant with the cessation of steroids. Maintenance levels of Tacrolimus were kept at < 4 ng/ml, while Sirolimus levels were kept at 6-8 ng/ml. We compared outcomes with that of our historical controls, treated with Sirolimus and Tacrolimus, who did not discontinue steroids.

RESULTS:

The recipients on prednisone-free maintenance immunosuppression had excellent 1, 5, and 10 yr. actuarial patient survival (99%, 94%, and 77%) and graft survival (97%, 87%, and 64%) when compared to controls. Acute rejection rates were also comparable to well matched controls with 1, 5, and 10 year acute rejection rates of 8%, 15%, and 26%. The mean serum creatinine level (+/-SD) at one yr. was 1.5 +/- 0.24 mg/dL. At 3 years it was 1.34 +/- 0.25, and at 5 years was 1.42 +/- 0.42. Close to 90% of kidney recipients with functioning grafts remain steroid-free as of 2013. Additionally, recipients on the steroid-free protocol had decreased prevalence of four risk factors for cardiovascular disease when compared with historical controls: hypertension, hyperlipidemia, weight gain, and incidence of post-transplant diabetes.

CONCLUSION:

Early steroid-withdrawal in renal transplant recipients in conjunction with Mycophenolate, Sirolimus, and CNI minimization is a safe and effective maintenance protocol with equivalent graft survival, patient survival, and acute rejection rates to steroid-based protocols with improvement in cardiovascular risk profiles.

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To cite this abstract in AMA style:

Lopez-Soler R, Park L, Martinolich J, Conti D. Early Steroid Withdrawal and Calcineurin Inhibitor Minimization Protocols for Maintenance Immunosuppression: A Single Center 10-Year Experience [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/early-steroid-withdrawal-and-calcineurin-inhibitor-minimization-protocols-for-maintenance-immunosuppression-a-single-center-10-year-experience/. Accessed May 8, 2025.

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