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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

RECORD 2017.

Methods
  • Design: open‐label RCT

  • Duration: 28 August 2012 to 23 February 2015.

  • Follow up: 12 months

Participants
  • Setting: multicentre (7 centres)

  • Countries: Korea

  • Kidney transplant recipients DD or LRD; > 20 years

  • Number (group 1/group 2): 151 (76/75)

  • Mean age ± SD (years): group 1 (46.1 ± 13.0); group 2 (46.0 ± 10.8)

  • Sex (M/F): group 1 (57/21); group 2 (53/22)

  • Exclusions: multi‐organ recipients or a kidney donated after cardiac death; ATG induction; desensitisation pre‐transplantation; identical HLA matching between donor and recipient; cold ischaemic time of > 30 hours; leukocyte count < 2500/L, neutrophil count < 1500/L or platelet count < 100,000/L; recipient with HBV or HCV infection; history of any cancer, except successfully treated localized non‐ melanoma skin cancer; ABO‐incompatible transplants.

Interventions Treatment group 1
  • SRL: 2 mg within 24 hours of reperfusion; levels 3 to 5 ng/mL

  • ER‐TAC: LRD 0.2 mg/kg 2 days before transplant. DD 0.1 mg /kg on day of transplant. Levels 3 to 12 ng/mL 1st month, then 3 to 8 ng/mL; commenced within 48 hours of transplant


Treatment group 2
  • MMF: 500 mg within 24 hours of reperfusion; 1000 mg to 2000 mg/d

  • ER‐TAC: LRD 0.2 mg/kg 2 days before transplant. DD 0.1 mg /kg on day of transplant. Levels 3 to 12 ng/mL 1st month, then 3 to 8 ng/mL; commenced within 48 hours of transplant


Co‐interventions
  • Basiliximab: 20 mg

  • Prednisolone

Outcomes
  • Efficacy failure

  • BPAR

  • Graft loss

  • Patient death/patient loss to follow‐up

  • eGFR (MDRD)

  • Overall survival and graft survival

Notes
  • Comparison TOR‐I versus antimetabolite

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization was centrally released by an electronic case report form before transplantation. Randomization code was generated and performed using a block designed stratified by each site"
Allocation concealment (selection bias) Low risk Quote: "randomization was centrally released by an electronic case report form before transplantation. Randomization code was generated and performed using a block designed stratified by each site"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk All blinded before randomisation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome BPAR, graft loss and patient death and unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk All patients accounted for but greater than 10% not analysed
Selective reporting (reporting bias) Low risk All pre‐specified outcomes mentioned
Other bias High risk Pharma funded study. Funded by Astellas