A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients

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A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients. / Ekberg, Jana; Baid-Agrawal, Seema; Jespersen, Bente et al.

In: Kidney international reports, Vol. 7, No. 2, 02.2022, p. 259-269.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

Harvard

Ekberg, J, Baid-Agrawal, S, Jespersen, B, Källen, R, Rafael, E, Skov, K & Lindnér, P 2022, 'A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients', Kidney international reports, vol. 7, no. 2, pp. 259-269. https://doi.org/10.1016/j.ekir.2021.11.028

APA

Ekberg, J., Baid-Agrawal, S., Jespersen, B., Källen, R., Rafael, E., Skov, K., & Lindnér, P. (2022). A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients. Kidney international reports, 7(2), 259-269. https://doi.org/10.1016/j.ekir.2021.11.028

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Author

Ekberg, Jana ; Baid-Agrawal, Seema ; Jespersen, Bente et al. / A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients. In: Kidney international reports. 2022 ; Vol. 7, No. 2. pp. 259-269.

Bibtex

@article{2804995dbaca4193a12f654dff4500fb,
title = "A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients",
abstract = "Introduction: Steroid-based immunosuppression after transplantation increases the risk of post-transplant diabetes mellitus (PTDM), with adverse effects on patient and graft survival. In the SAILOR study, we investigated the safety and efficacy of complete steroid avoidance in immunologically low-risk kidney recipients without diabetes on the current standard-of-care maintenance regimen with tacrolimus/mycophenolate mofetil (MMF). Methods: In this 2-year, multicenter, open-label trial, a total of 222 patients were randomized to receive either steroid avoidance protocol (tacrolimus/MMF/antithymocyte globulin [ATG] induction [n = 113]) or steroid maintenance protocol (tacrolimus/MMF/prednisolone/basiliximab-induction [n = 109]). Results: At 1 year, no significant differences were found between steroid avoidance and steroid maintenance arms in the incidence of PTDM, the primary end point (12.4% vs. 18.3%, respectively, P = 0.30, CI: 16.3–4.4), or in overall biopsy-proven rejections (15% vs. 13.8%, respectively, P = 0.85). At 2 years, the composite end point of freedom from acute rejection, graft loss, and death (81% vs. 85%, respectively, P = 0.4), kidney function, or adverse events was comparable between the 2 arms. Moreover, 63.9% of the patients in the steroid avoidance arm remained free from steroids at 2 years. Conclusion: The SAILOR study provides further evidence for the feasibility, safety, and efficacy of early steroid-free treatment at 2 years in immunologically low-risk kidney recipients with tacrolimus/MMF maintenance regimen.",
keywords = "biopsy-proven rejection, kidney transplantation, post-transplantation diabetes mellitus, steroid avoidance",
author = "Jana Ekberg and Seema Baid-Agrawal and Bente Jespersen and Ragnar K{\"a}llen and Ehab Rafael and Karin Skov and Per Lindn{\'e}r",
year = "2022",
month = feb,
doi = "10.1016/j.ekir.2021.11.028",
language = "English",
volume = "7",
pages = "259--269",
journal = "Kidney international reports",
issn = "2468-0249",
publisher = "Elsevier Science Publishing Co., Inc. (New York)",
number = "2",

}

RIS

TY - JOUR

T1 - A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients

AU - Ekberg, Jana

AU - Baid-Agrawal, Seema

AU - Jespersen, Bente

AU - Källen, Ragnar

AU - Rafael, Ehab

AU - Skov, Karin

AU - Lindnér, Per

PY - 2022/2

Y1 - 2022/2

N2 - Introduction: Steroid-based immunosuppression after transplantation increases the risk of post-transplant diabetes mellitus (PTDM), with adverse effects on patient and graft survival. In the SAILOR study, we investigated the safety and efficacy of complete steroid avoidance in immunologically low-risk kidney recipients without diabetes on the current standard-of-care maintenance regimen with tacrolimus/mycophenolate mofetil (MMF). Methods: In this 2-year, multicenter, open-label trial, a total of 222 patients were randomized to receive either steroid avoidance protocol (tacrolimus/MMF/antithymocyte globulin [ATG] induction [n = 113]) or steroid maintenance protocol (tacrolimus/MMF/prednisolone/basiliximab-induction [n = 109]). Results: At 1 year, no significant differences were found between steroid avoidance and steroid maintenance arms in the incidence of PTDM, the primary end point (12.4% vs. 18.3%, respectively, P = 0.30, CI: 16.3–4.4), or in overall biopsy-proven rejections (15% vs. 13.8%, respectively, P = 0.85). At 2 years, the composite end point of freedom from acute rejection, graft loss, and death (81% vs. 85%, respectively, P = 0.4), kidney function, or adverse events was comparable between the 2 arms. Moreover, 63.9% of the patients in the steroid avoidance arm remained free from steroids at 2 years. Conclusion: The SAILOR study provides further evidence for the feasibility, safety, and efficacy of early steroid-free treatment at 2 years in immunologically low-risk kidney recipients with tacrolimus/MMF maintenance regimen.

AB - Introduction: Steroid-based immunosuppression after transplantation increases the risk of post-transplant diabetes mellitus (PTDM), with adverse effects on patient and graft survival. In the SAILOR study, we investigated the safety and efficacy of complete steroid avoidance in immunologically low-risk kidney recipients without diabetes on the current standard-of-care maintenance regimen with tacrolimus/mycophenolate mofetil (MMF). Methods: In this 2-year, multicenter, open-label trial, a total of 222 patients were randomized to receive either steroid avoidance protocol (tacrolimus/MMF/antithymocyte globulin [ATG] induction [n = 113]) or steroid maintenance protocol (tacrolimus/MMF/prednisolone/basiliximab-induction [n = 109]). Results: At 1 year, no significant differences were found between steroid avoidance and steroid maintenance arms in the incidence of PTDM, the primary end point (12.4% vs. 18.3%, respectively, P = 0.30, CI: 16.3–4.4), or in overall biopsy-proven rejections (15% vs. 13.8%, respectively, P = 0.85). At 2 years, the composite end point of freedom from acute rejection, graft loss, and death (81% vs. 85%, respectively, P = 0.4), kidney function, or adverse events was comparable between the 2 arms. Moreover, 63.9% of the patients in the steroid avoidance arm remained free from steroids at 2 years. Conclusion: The SAILOR study provides further evidence for the feasibility, safety, and efficacy of early steroid-free treatment at 2 years in immunologically low-risk kidney recipients with tacrolimus/MMF maintenance regimen.

KW - biopsy-proven rejection

KW - kidney transplantation

KW - post-transplantation diabetes mellitus

KW - steroid avoidance

UR - http://www.scopus.com/inward/record.url?scp=85121737839&partnerID=8YFLogxK

U2 - 10.1016/j.ekir.2021.11.028

DO - 10.1016/j.ekir.2021.11.028

M3 - Journal article

C2 - 35155865

VL - 7

SP - 259

EP - 269

JO - Kidney international reports

JF - Kidney international reports

SN - 2468-0249

IS - 2

ER -