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).
  
  
  CONCLUSIONS
  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.
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL. Electronic address: gciancio@med.miami.edu.
authors: G
authors: G
authors: Ciancio
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: P
authors: P
authors: Tryphonopoulos
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: J J
authors: JJ
authors: Gaynor
authors: Division of Nephrology of the Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.
authors: G
authors: G
authors: Guerra
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: J
authors: J
authors: Sageshima
authors: Division of Nephrology of the Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.
authors: D
authors: D
authors: Roth
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: L
authors: L
authors: Chen
authors: Division of Nephrology of the Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.
authors: W
authors: W
authors: Kupin
authors: Division of Nephrology of the Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.
authors: A
authors: A
authors: Mattiazzi
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: L
authors: L
authors: Tueros
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: S
authors: S
authors: Flores
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: L
authors: L
authors: Hanson
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: R H
authors: RH
authors: Powell
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: P
authors: P
authors: Ruiz
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: R
authors: R
authors: Vianna
authors: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center and the Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, FL.
authors: G W
authors: GW
authors: Burke
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000077552:Basiliximab; D004359:Drug Therapy, Combination; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage*; D010865:Pilot Projects; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D016559:Tacrolimus / Q000008:administration & dosage*
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D000068338:Everolimus; C512542:thymoglobulin; D009173:Mycophenolic Acid; D016559:Tacrolimus