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A randomized, prospective comparison of transition to sirolimus‐based CNI ‐minimization or withdrawal in African American kidney transplant recipients
Author(s) -
Fleming James N.,
Taber David J.,
Pilch Nicole A.,
McGillicuddy John W.,
Srinivas Titte R.,
Baliga Prabhakar K.,
Chavin Kenneth D.,
Bratton Charles F.
Publication year - 2016
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12718
Subject(s) - medicine , sirolimus , discontinuation , calcineurin , regimen , urology , prospective cohort study , kidney transplantation , randomized controlled trial , renal function , surgery , kidney , transplantation
Abstract Background There is a lack of conclusive evidence to suggest if calcineurin inhibitor ( CNI ) withdrawal or minimization with sirolimus is the best strategy for African Americans. Methods This was a randomized, prospective, open‐label, pilot study comparing the two mammalian target of rapamycin ( mTOR ) transition strategies in adult African Americans between six and 24 wk post‐transplant. The primary outcome was a comparison of the eGFR at one yr after conversion. Results Forty patients were randomized and analyzed in an intent‐to‐treat fashion. Median day of transition was day 96 (withdrawal) and 68 (minimization). Patients in the CNI ‐withdrawal group (n = 23) had significantly higher eGFR at one yr compared to the CNI ‐minimization group (n = 17, 73 vs. 56 mL/min, p = 0.03), as well as a significantly larger increase in eGFR from baseline (12 vs. 5 mL/min, p = 0.03). There were no differences in infections, acute rejection, death, or graft loss. Both regimens were constrained by disproportionately high discontinuation rates despite modest toxicity profiles. Conclusion In spite of considerable withdrawal rate across both study arms, African American kidney transplant recipients who underwent early transition to a sirolimus‐based CNI ‐withdrawal regimen had significantly better graft function at one yr compared to those transitioned to a sirolimus‐based CNI ‐minimization regimen. Clinicaltrials.gov identifier: NCT 01005706.