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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

EARTS Study 1999.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 1 year

Participants
  • Country: Finland/Sweden/Norway/Germany

  • Setting: multicentre (10)

  • Inclusion criteria: adult DD kidney transplant recipients

  • Number: treatment group (131); control group (131)

  • Mean age, range (years): treatment group (48.0, 21 to 78); control group (45.1, 16 to 77)

  • Sex (M/F): treatment group (83/48); control group (89/42)

  • Exclusion criteria: history of malignancy; previous exposure to murine antibodies; active infection; ongoing pregnancy

Interventions Treatment group
  • Enlimomab: 160 mg IV 3 hours prior to transplant, then 40 mg/d for 5 days

  • CSA/AZA/PRED per local protocol


Placebo
  • CSA/AZA/PRED per local protocol


17 patients across both groups got ATG for DGF
Outcomes
  • Death

  • Graft loss

  • Acute rejection ‐ at 3 months and 1 year

  • DGF

  • Infections

  • Malignancy

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'Performed in blocks of 6 to ensure balanced distribution of treatment per centre'
Allocation concealment (selection bias) Low risk Central allocation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Double‐blinded; pathologist reviewing biopsies for suspected acute rejection was also blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Unclear risk All expected outcomes reported
Other bias Unclear risk Appears free from other bias but funding source not declared