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

Ackermann 1988.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 3 to 12 months

Participants
  • Country: USA

  • Setting: single centre (Florida)

  • Inclusion criteria: adult (> 16 years) DD kidney transplant recipients (100%); financial resources for CSA therapy after discharge

  • Number: treatment group (33); control group (33)

  • Mean age ± SD (years): not reported

  • Sex (M/F): treatment group (21/12); control group (23/12)

  • Ethnicity (other/African American): treatment group (23/10); control group (21/12)

  • Exclusion criteria: fluid overload (unresolved by dialysis); previous exposure to OKT3, pregnant or lactating women

Interventions Treatment group
  • OKT3: 5 mg/d IV for 14 days

  • CSA: started day 11, target trough 300 to 500 ng/mL


Control group
  • CSA: twice daily started day 1 (unsure), target trough level 300 to 500 ng/mL


Immunosuppression (both groups)
  • AZA: 2.5 mg/kg (adjusted per WCC and kidney function)

  • MP‐PRED: 2 g IV intra‐op then PRED 0.25 mg/kg/d

Outcomes
  • Death

  • Graft loss

  • Acute rejection

  • DGF

  • Infection

  • Graft function

Notes
  • Outcomes reported for 3 months only as some patients only followed to 3 months at time of reporting (some but NOT all patients followed for 12 months)

  • Funding source: "Supported by a grant from Othro Pharmaceutical Corp (Raritan, NJ)

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 'Randomized by sealed envelope draw'
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unblinded but not likely to influence most outcomes; may influence reporting of infections
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not certain if acute rejection was biopsy‐proven or clinically diagnosed
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 High risk Grant from Ortho Pharmaceutical Corp (OKT3 manufacturer)