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

Hanto 1991.

Methods

  • Study design: parallel RCT

  • Study duration: May 1987 to December 1989

  • Study follow‐up: 3 years
Participants

  • Country: USA

  • Setting: single centre

  • Inclusion criteria: adult 1st DD kidney transplant recipients

  • Number: treatment group 1 (59); treatment group 2 (58)

  • Mean age ± SD (years): treatment group 1 (43 ± 11); treatment group 2 (44 ± 11)

  • Sex (M/F): treatment group 1 (31/28); treatment group 2 (40/18)

  • Ethnicity (white/black/other): treatment group 1 (40/19/0); treatment group 2 (31/26/1)

  • Exclusion criteria: not reported
Interventions Treatment group 1

  • ALG (Minnesota): 20 mg/kg/d for 7 days, ALG given 6 to 12 hours post‐op (risk of low platelets and bleeding)


Treatment group 2

  • OKT3: 5 mg/d for 7 days (given intra‐op)


Maintenance immunosuppression (both groups)

  • AZA: 2.5 mg/kg pre‐op then 2 to 2.5 mg/kg/d to maintain WCC > 3000/mm3

  • MP: 7 mg/kg pre‐op, then PRED 1 mg/kg, tapered to 0.3 mg/kg by 3 months, and 0.15 mg/kg by 12 months

  • CSA: 8 mg/kg/d from day 5 post‐op, trough level 175 to 200 ng/mL trough, tapered to 5 mg/kg by 9 months
Outcomes

  • Death

  • Graft loss

  • Acute rejection

  • CMV disease

  • Graft function
Notes

  • Infections reported but only as total number and number per patient (not reported as number of patients with infection)

  • Monitoring of CD3, 4 and 8 cells in both groups

  • 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) High risk All expected outcomes reported; unable to meta‐analyse infection data
Other bias Unclear risk Funding source not reported