title: Steroid or tacrolimus withdrawal in renal transplant recipients using sirolimus.
abstract: BACKGROUND
  Calcineurin inhibitor (CNI) and steroid (ST) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens. We conducted a single center, prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen.
  
  
  METHODS
  Forty-seven recipients of first renal transplant with non-HLA-identical living donors received sirolimus (SRL), tacrolimus (TAC), and ST without induction therapy and were randomized to undergo ST (TAC/SRL group, n = 24) or TAC (SRL/ST group, n = 21) withdrawal 3 months after transplantation. Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection (BCAR) and renal function at 12 months.
  
  
  RESULTS
  No differences were observed in the incidence of BCAR (4.2% vs. 9.5%), graft (95.8% vs. 95.6%), and patient (95.8% vs. 95.6%) survivals or in renal function (60 ± 11.5 vs. 63.4 ± 10.5 ml/min, P = 0.361). Higher mean cholesterol concentration was observed in the SRL/ST group (191.9 ± 63.3 vs. 241.6 ± 61.5 mg/dl, P = 0.019). Treatment discontinuation due to adverse events occurred in 12.5% of patients in TAC/SRL group and 21.7% in SRL/ST group.
  
  
  CONCLUSIONS
  Within this short period of observation, our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies.
authors.affiliation: Nephrology Division, Hospital do Rim e Hipertensão, Rua Borges Lagoa 960, 11° andar, Vila Clementino, 04038-002 São Paulo, Brazil. taina.sandes@medfarm.com.br
authors.forename: Tainá Veras
authors.initials: TV
authors.lastname: de Sandes Freitas
authors.forename: Kelly Miyuki
authors.initials: KM
authors.lastname: Harada
authors.forename: Cláudia Rosso
authors.initials: CR
authors.lastname: Felipe
authors.forename: Nelson Zocoler
authors.initials: NZ
authors.lastname: Galante
authors.forename: Edison Luiz Mandia
authors.initials: EL
authors.lastname: Sampaio
authors.forename: Edson
authors.initials: E
authors.lastname: Ikehara
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfieri
authors.forename: Hélio
authors.initials: H
authors.lastname: Tedesco-Silva Júnior
authors.forename: José Osmar
authors.initials: JO
authors.lastname: Medina-Pestana
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001706:Biopsy; D065095:Calcineurin Inhibitors; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006084:Graft Rejection / Q000473:pathology* / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000009:adverse effects / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000276:immunology / Q000473:pathology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D011241:Prednisone; D020123:Sirolimus; D016559:Tacrolimus; D008775:Methylprednisolone