title: A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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: NCT01005706.
authors.affiliation: Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: James N
authors.initials: JN
authors.lastname: Fleming
authors.affiliation: Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.|Department of Pharmacy, Ralph H Johnson VAMC, Charleston, SC, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Taber
authors.affiliation: Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Nicole A
authors.initials: NA
authors.lastname: Pilch
authors.affiliation: Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: John W
authors.initials: JW
authors.lastname: McGillicuddy
authors.affiliation: Department of Nephrology, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Titte R
authors.initials: TR
authors.lastname: Srinivas
authors.affiliation: Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Prabhakar K
authors.initials: PK
authors.lastname: Baliga
authors.affiliation: Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Chavin
authors.affiliation: Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Bratton
mesh_terms: D001741:Black or African American; D065095:Calcineurin Inhibitors; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000453:epidemiology*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000627:therapeutic use*; D066027:Transplant Recipients; D014481:United States / Q000453:epidemiology; D028761:Withholding Treatment
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D020123:Sirolimus
keywords: kidney; mammalian target of rapamycin; minimization; transplant; withdrawal