title: Surveillance Registry of Sirolimus Use in Recipients of Kidney Allografts From Expanded Criteria Donors.
abstract: BACKGROUND
  The use of expanded criteria donor (ECD) kidneys has increased the overall availability of renal transplants. This study assessed the use of sirolimus in patients receiving Argentina-ECD kidneys.
  
  
  METHODS
  This observational, open-label, 1-arm, prospective, longitudinal pilot study was conducted at 8 transplant centers in Argentina. Adults receiving kidney transplants (without pancreas) from ECDs were eligible if they were converted to sirolimus 1 to 36 months' posttransplantation, with sirolimus becoming base therapy within 1 month after conversion. Patients were followed up for 1 year. Outcomes included reasons for conversion, acute rejection, patient and graft survival, graft status, and safety.
  
  
  RESULTS
  The intention-to-treat population included 52 patients (mean age, 48.7 years). Calcineurin inhibitor nephropathy (40%) and chronic allograft nephropathy (25%) were the most frequent reasons for conversion. Two acute rejections occurred during follow-up, but no patients experienced graft loss. One patient died during follow-up, and 3 patients died within 1 month of the last sirolimus dose. Levels of serum creatinine and creatinine clearance remained stable from baseline to week 52/53. Mean proteinuria measured in a subset of patients was 0.2 ± 0.2 g/24 hours before conversion and increased to 0.6 ± 1.2 g/24 hours at week 24/25 and 0.5 ± 0.6 g/24 hours at week 52/53. Adverse events were consistent with those in previous conversion trials; the most common were infections and infestations (54%).
  
  
  CONCLUSIONS
  This pilot study illustrates the potential benefits of sirolimus in recipients of ECD kidneys in Argentina. Larger, randomized controlled trials are needed to confirm these findings and to clarify the long-term benefits of sirolimus in this patient population.
authors: CEMIC, Buenos Aires, Argentina. Electronic address: guslaham@yahoo.com.ar.
authors: G
authors: G
authors: Laham
authors: Pfizer, Argentina Region.
authors: R
authors: R
authors: Scuteri
authors: Pfizer, Argentina Region.
authors: P
authors: P
authors: Cornicelli
authors: Clinic of Nephrology and Urology, Santa Fe, Argentina.
authors: M
authors: M
authors: Arriola
authors: Fundación Favaloro, Buenos Aires, Argentina.
authors: P M
authors: PM
authors: Raffaele
authors: CEMIC, Buenos Aires, Argentina.
authors: M
authors: M
authors: Davalos Michel
authors: Hospital Italiano, Buenos Aires, Argentina.
authors: N
authors: N
authors: Imperiali
authors: Fundación Favaloro, Buenos Aires, Argentina.
authors: R M
authors: RM
authors: Fortunato
authors: Sanatorio Mitre, Buenos Aires, Argentina.
authors: E C
authors: EC
authors: Maggiora
authors: Centro de Trasplante, Tucumán, Argentina.
authors: M V
authors: MV
authors: Sal
authors: CEMIC, Buenos Aires, Argentina.
authors: G
authors: G
authors: Soler Pujol
mesh_terms: D000328:Adult; D000368:Aged; D064591:Allografts; D001118:Argentina; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000401:mortality; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000627:therapeutic use*; D014019:Tissue Donors / Q000600:supply & distribution*
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus