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

Toledo‐Pereyra 1985.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 1 year

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: 1st DD kidney transplant recipients

  • Number: treatment group 1 (25); treatment group 2 (25)

  • Mean age (years): treatment group 1 (47); treatment group 2 (42)

  • Sex (M/F): treatment group 1 (18/7); treatment group 2 (16/9)

  • Black/white: treatment group 1 (11/14); treatment group 2 (5/20)

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • Horse or goat ALG: 20 mg/kg/d, starting 1 day post‐op, for 14 days; adjust as per WCC and platelets (dose 5 to 20 mg/kg/d)

    • Dose adjusted if platelets fell to 50 to 100 x 103/mm3, or WCC 3000 to 5000/mm3

    • Stopped if platelets < 50,000/mm3 or WCC < 3000/mm3


Treatment group 2
  • hATG: up to 15 mg/kg/d, started 1 day post‐op, continued for 14 days at dose 5 to 15 mg/kg/d

    • Dose adjusted if platelets fell to 50 to 100 x 103/mm3, or WCC 3000 to 5000/mm3

    • Stopped if platelets < 50,000/mm3 or WCC < 3000/mm3


Immunosuppression (both groups)
  • AZA 5mg/kg/d on 1st day post‐op, then 1 to 2.5 mg/kg/d as per WCC

  • PRED: 1 mg/kg/d, reduced to 20 to 25 mg/d by 3rd or 4th week

Outcomes
  • Death

  • Graft loss

  • Acute rejection

  • Side effects

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Unlikely to influence outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Low risk All expected outcomes reported
Other bias Unclear risk Funding source not reported