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

Grino 1991.

Methods
  • Study design: parallel RCT

  • Study duration: March 1988 to December 1990

  • Study follow‐up: 2 years

Participants
  • Country: Spain

  • Setting: single centre

  • Inclusion criteria: 1st DD kidney transplant recipients

  • Number: treatment group 1 (68); treatment group 2 (72)

  • Mean age ± SD (years): treatment group 1 (42.6 ± 13); treatment group 2 (39 ± 11)

  • Sex (M): treatment group 1 (59%); treatment group 2 (57%)

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • Horse ALG: 15 mg/kg pre‐transplant, 12 mg/kg day 1, then 10 mg/kg alternate days for 4 doses

    • Dose adjusted to maintain CD3 counts 10% to 20%


Treatment group 2
  • OKT3: 5mg IV at induction, continued daily for 5 doses total


Immunosuppression (both groups)
  • MP: 1 mg/kg in operating theatre, then 0.25 mg/kg, then taper to 0.1 mg/kg

  • CSA: 3 mg/kg IV pre‐op, then 3 mg/kg in 2 doses post‐op, then oral 8 mg/kg in 2 doses

Outcomes
  • Death

  • Graft loss

  • DGF

  • Acute rejection

  • Serious infection

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) Low risk "randomly allocated by a closed‐envelope technique"
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