Pilot Randomized Trial of Tacrolimus/Everolimus vs Tacrolimus/Enteric-Coated Mycophenolate Sodium in Adult, Primary Kidney Transplant Recipients at a Single Center

Gaetano Ciancio, P. Tryphonopoulos, Jeffrey Gaynor, Giselle Guerra, J. Sageshima, David Roth, Linda J Chen, Warren Kupin, Adela D Mattiazzi, L. Tueros, S. Flores, L. Hanson, R. H. Powell, Phillip Ruiz, Rodrigo Vianna, George W Burke

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients. Methods We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non−highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B). In both treatment arms, dual induction therapy consisting of anti-thymocyte globulin (Thymoglobulin) and basiliximab was given. Early corticosteroid withdrawal (by 7–10 days posttransplantation) was also planned in both arms. There were 30 study participants, 15 per treatment arm. Results during the first 12 months posttransplantation are reported here. Results Between 1 month and 12 months posttransplantation, mean TAC trough levels ranged between 5 and 8 ng/mL in both arms. Mean trough EVL level in Group A ranged between 4 and 6 ng/mL, and mean EC-MPS dose in Group B ranged from 1440 mg at 1 month to 945 mg at 12 months. One patient in Group A vs three patients in Group B experienced a first biopsy-proven acute rejection during the first 12 months posttransplantation (P =.32). Four patients in each group experienced biopsy-proven chronic allograft injury (interstitial fibrosis/tubular atrophy) (P =.99). There was a slight trend toward more favorable renal function in Group A at months 1–3 posttransplantation (P =.06,.10, and.18 for estimated glomerular filtration rate, respectively). No graft failures or deaths were observed in either group during the first 12 months posttransplantation. Four patients in each group developed an infection during the first 12 months posttransplantation. Two patients in Group A developed new-onset diabetes after transplant during the 12-month follow-up period, vs no patients in Group B (P =.13). Conclusion TAC/EVL may be a viable alternative to TAC/EC-MPS for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients and should be given further consideration.

Original languageEnglish (US)
Pages (from-to)2006-2010
Number of pages5
JournalTransplantation Proceedings
Volume48
Issue number6
DOIs
StatePublished - Jul 1 2016

Fingerprint

Mycophenolic Acid
Tacrolimus
Kidney
Arm
Maintenance
Immunosuppression
Transplants
Biopsy
Antilymphocyte Serum
Transplant Recipients
Everolimus
Glomerular Filtration Rate
Atrophy
Allografts
Adrenal Cortex Hormones
Fibrosis
Therapeutics
Wounds and Injuries
Infection

ASJC Scopus subject areas

  • Surgery
  • Transplantation

Cite this

@article{d545638eb0e34cdb83a0415a4e025acd,
title = "Pilot Randomized Trial of Tacrolimus/Everolimus vs Tacrolimus/Enteric-Coated Mycophenolate Sodium in Adult, Primary Kidney Transplant Recipients at a Single Center",
abstract = "Background Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients. Methods We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non−highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B). In both treatment arms, dual induction therapy consisting of anti-thymocyte globulin (Thymoglobulin) and basiliximab was given. Early corticosteroid withdrawal (by 7–10 days posttransplantation) was also planned in both arms. There were 30 study participants, 15 per treatment arm. Results during the first 12 months posttransplantation are reported here. Results Between 1 month and 12 months posttransplantation, mean TAC trough levels ranged between 5 and 8 ng/mL in both arms. Mean trough EVL level in Group A ranged between 4 and 6 ng/mL, and mean EC-MPS dose in Group B ranged from 1440 mg at 1 month to 945 mg at 12 months. One patient in Group A vs three patients in Group B experienced a first biopsy-proven acute rejection during the first 12 months posttransplantation (P =.32). Four patients in each group experienced biopsy-proven chronic allograft injury (interstitial fibrosis/tubular atrophy) (P =.99). There was a slight trend toward more favorable renal function in Group A at months 1–3 posttransplantation (P =.06,.10, and.18 for estimated glomerular filtration rate, respectively). No graft failures or deaths were observed in either group during the first 12 months posttransplantation. Four patients in each group developed an infection during the first 12 months posttransplantation. Two patients in Group A developed new-onset diabetes after transplant during the 12-month follow-up period, vs no patients in Group B (P =.13). Conclusion TAC/EVL may be a viable alternative to TAC/EC-MPS for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients and should be given further consideration.",
author = "Gaetano Ciancio and P. Tryphonopoulos and Jeffrey Gaynor and Giselle Guerra and J. Sageshima and David Roth and Chen, {Linda J} and Warren Kupin and Mattiazzi, {Adela D} and L. Tueros and S. Flores and L. Hanson and Powell, {R. H.} and Phillip Ruiz and Rodrigo Vianna and Burke, {George W}",
year = "2016",
month = "7",
day = "1",
doi = "10.1016/j.transproceed.2016.03.048",
language = "English (US)",
volume = "48",
pages = "2006--2010",
journal = "Transplantation Proceedings",
issn = "0041-1345",
publisher = "Elsevier USA",
number = "6",

}

TY - JOUR

T1 - Pilot Randomized Trial of Tacrolimus/Everolimus vs Tacrolimus/Enteric-Coated Mycophenolate Sodium in Adult, Primary Kidney Transplant Recipients at a Single Center

AU - Ciancio, Gaetano

AU - Tryphonopoulos, P.

AU - Gaynor, Jeffrey

AU - Guerra, Giselle

AU - Sageshima, J.

AU - Roth, David

AU - Chen, Linda J

AU - Kupin, Warren

AU - Mattiazzi, Adela D

AU - Tueros, L.

AU - Flores, S.

AU - Hanson, L.

AU - Powell, R. H.

AU - Ruiz, Phillip

AU - Vianna, Rodrigo

AU - Burke, George W

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Background Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients. Methods We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non−highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B). In both treatment arms, dual induction therapy consisting of anti-thymocyte globulin (Thymoglobulin) and basiliximab was given. Early corticosteroid withdrawal (by 7–10 days posttransplantation) was also planned in both arms. There were 30 study participants, 15 per treatment arm. Results during the first 12 months posttransplantation are reported here. Results Between 1 month and 12 months posttransplantation, mean TAC trough levels ranged between 5 and 8 ng/mL in both arms. Mean trough EVL level in Group A ranged between 4 and 6 ng/mL, and mean EC-MPS dose in Group B ranged from 1440 mg at 1 month to 945 mg at 12 months. One patient in Group A vs three patients in Group B experienced a first biopsy-proven acute rejection during the first 12 months posttransplantation (P =.32). Four patients in each group experienced biopsy-proven chronic allograft injury (interstitial fibrosis/tubular atrophy) (P =.99). There was a slight trend toward more favorable renal function in Group A at months 1–3 posttransplantation (P =.06,.10, and.18 for estimated glomerular filtration rate, respectively). No graft failures or deaths were observed in either group during the first 12 months posttransplantation. Four patients in each group developed an infection during the first 12 months posttransplantation. Two patients in Group A developed new-onset diabetes after transplant during the 12-month follow-up period, vs no patients in Group B (P =.13). Conclusion TAC/EVL may be a viable alternative to TAC/EC-MPS for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients and should be given further consideration.

AB - Background Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients. Methods We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non−highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B). In both treatment arms, dual induction therapy consisting of anti-thymocyte globulin (Thymoglobulin) and basiliximab was given. Early corticosteroid withdrawal (by 7–10 days posttransplantation) was also planned in both arms. There were 30 study participants, 15 per treatment arm. Results during the first 12 months posttransplantation are reported here. Results Between 1 month and 12 months posttransplantation, mean TAC trough levels ranged between 5 and 8 ng/mL in both arms. Mean trough EVL level in Group A ranged between 4 and 6 ng/mL, and mean EC-MPS dose in Group B ranged from 1440 mg at 1 month to 945 mg at 12 months. One patient in Group A vs three patients in Group B experienced a first biopsy-proven acute rejection during the first 12 months posttransplantation (P =.32). Four patients in each group experienced biopsy-proven chronic allograft injury (interstitial fibrosis/tubular atrophy) (P =.99). There was a slight trend toward more favorable renal function in Group A at months 1–3 posttransplantation (P =.06,.10, and.18 for estimated glomerular filtration rate, respectively). No graft failures or deaths were observed in either group during the first 12 months posttransplantation. Four patients in each group developed an infection during the first 12 months posttransplantation. Two patients in Group A developed new-onset diabetes after transplant during the 12-month follow-up period, vs no patients in Group B (P =.13). Conclusion TAC/EVL may be a viable alternative to TAC/EC-MPS for use as standard maintenance immunosuppression in non−highly sensitized kidney transplant recipients and should be given further consideration.

UR - http://www.scopus.com/inward/record.url?scp=84995876950&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84995876950&partnerID=8YFLogxK

U2 - 10.1016/j.transproceed.2016.03.048

DO - 10.1016/j.transproceed.2016.03.048

M3 - Article

C2 - 27569936

AN - SCOPUS:84995876950

VL - 48

SP - 2006

EP - 2010

JO - Transplantation Proceedings

JF - Transplantation Proceedings

SN - 0041-1345

IS - 6

ER -