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

Cole 1994.

Methods
  • Study design: parallel RCT, stratified for the DM and for each centre

  • Study duration: not reported

  • Study follow‐up: 1 year

Participants
  • Country: USA

  • Setting: multicentre (3)

  • Inclusion criteria: adult 1st DD kidney transplant recipients

  • Number: treatment group 1 (83); treatment group 2 (83)

  • Mean age, range (years): treatment group 1 (48.43, 22 to 72); treatment group 2 (47.31, 22 to 70)

  • Males: treatment group 1 (66%); treatment group 2 (60%)

  • Exclusion criteria: refused consent; positive skin test to rATG

Interventions Treatment group 1
  • RATG: 0.15 mL/kg/d as continuous IV infusion within 12 h of transplant; adjusted to keep lymphocyte count < 200/mL3; given for 10 to 14 days

  • CSA initiated at 2 mg/kg twice daily once kidney function was established (SCr < 250 µmol/L) but at least 7 days after surgery; target trough of 100 to 300 ng/mL


Treatment group 2
  • OKT3: 5 mg given during operation prior to anastomosis, then 5 mg/d IV infusion

    • MP: 1 mg/kg IV plus 50 mg oral or IV Benadryl and 650 mg acetaminophen every 6 h were given 1 h before OKT3 administration for the 1st 2 or 3 doses

    • CD3 levels not routinely monitored


Immunosuppression (both groups)
  • MP: 1 mg/kg IV within 1 h of transplant; 0.25 mg/kg every 6 h post‐op for 48 h; converted to PRED (0.5 mg/kg/d) then tapered to 0.2 mg/kg/d by day 11, 0.15 mg/kg/d by week 6 and continued for 1 year

  • AZA: 1 mg/kg IV within 1 h of transplant and then continued at 1 mg/kg/d for 1 year unless WCC > 3000/mL3

Outcomes
  • Death

  • Graft loss

  • Acute rejection

  • Infection (not able to be included in review as reported as total number of infections rather than total number of patients with infection)

Notes
  • Kidney function: SCr at 1, 3, 6 and 12 months 'similar' both groups (numbers not given)

  • 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 High risk Clinically diagnosed acute rejection (no biopsy‐proven acute rejection)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) High risk Expected outcomes reported, however infection data cannot be included in our meta‐analysis
Other bias Unclear risk Funding source not reported