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Kadry Z, Stine JG, Dohi T, et al. Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial. Transplant Direct. 2021;7(7):e709doi: 10.1097/TXD.0000000000001159.
Kadry, Z., Stine, J. G., Dohi, T., Jain, A., Robyak, K. L., Kwon, O., Hamilton, C. J., Janicki, P., Riley, T. R., Butt, F., Krok, K., Schreibman, I. R., Bezinover, D., Ghahramani, N., Campos, S., & Hollenbeak, C. S. (2021). Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial. Transplantation direct, 7(7), e709. https://doi.org/10.1097/TXD.0000000000001159
Kadry, Zakiyah, et al. "Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial." Transplantation direct vol. 7,7 (2021): e709. doi: https://doi.org/10.1097/TXD.0000000000001159
Kadry Z, Stine JG, Dohi T, Jain A, Robyak KL, Kwon O, Hamilton CJ, Janicki P, Riley TR, Butt F, Krok K, Schreibman IR, Bezinover D, Ghahramani N, Campos S, Hollenbeak CS. Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial. Transplant Direct. 2021 Jun 08;7(7):e709. doi: 10.1097/TXD.0000000000001159. eCollection 2021 Jul. PMID: 34124345; PMCID: PMC8191692.
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Transplant Direct. 2021 Jun 08;7(7):e709. doi: 10.1097/TXD.0000000000001159. eCollection 2021 Jul.

Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial.

Transplantation direct

Zakiyah Kadry, Jonathan G Stine, Takehiko Dohi, Ashokkumar Jain, Kimberly L Robyak, Osun Kwon, Christopher J Hamilton, Piotr Janicki, Thomas R Riley, Fauzia Butt, Karen Krok, Ian R Schreibman, Dmitri Bezinover, Nasrollah Ghahramani, Stalin Campos, Christopher S Hollenbeak

Affiliations

  1. Division of Transplantation, Department of Surgery, Penn State College of Medicine, Hershey, PA.
  2. Division of Gastroenterology and Hepatology, Department of Medicine, Penn State College of Medicine, Hershey, PA.
  3. Department of Pathology, Penn State College of Medicine, Hershey, PA.
  4. Division of Nephrology, Department of Medicine, Penn State College of Medicine, Hershey, PA.
  5. Department of Anesthesiology, Penn State College of Medicine, Hershey, PA.
  6. Department of Health Policy and Administration, Pennsylvania State University, University Park, PA.

PMID: 34124345 PMCID: PMC8191692 DOI: 10.1097/TXD.0000000000001159

Abstract

Renal dysfunction is associated with poor long-term outcomes after liver transplantation. We examined the renal sparing effect of everolimus (EVR) compared to standard calcineurin inhibitor (CNI) immunosuppression with direct measurements of renal function over 24 months.

METHODS: This was a prospective, randomized, open-label trial comparing EVR and mycophenolic acid (MPA) with CNI and MPA immunosuppression. An Investigational New Drug Application (IND # 113882) was obtained with the Food and Drug Administration as EVR is only approved for use with low-dose tacrolimus. Serum creatinine, 24-hour urine creatinine clearance, iothalamate clearance, Cockcroft-Gault creatinine clearance (CrCl), and Modification of Diet in Renal Disease estimated glomerular filtration rate were prospectively measured at 4 study visits. Nonparametric statistical tests were used for analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Effect size was measured using Cohen's

RESULTS: Each arm had 12 subjects; 4 patients dropped out in the EVR arm and 1 in the CNI arm by 24 months. Serum creatinine (

CONCLUSIONS: EVR with MPA resulted in significant long-term improvement in renal function and quality of life at 24 months after liver transplantation compared with standard CNI with MPA immunosuppression.

Copyright © 2021 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.

Conflict of interest statement

The authors declare no conflicts of interest.

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