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. 2010 Jan 20;2010(1):CD003897. doi: 10.1002/14651858.CD003897.pub3

Sollinger 2001.

Methods
  • Open‐label RCT

Participants
  • Setting: National multi centre (6)

  • Country: USA

  • Cadaveric (62%), first (81%) kidney transplant

  • Mean age (± SD)

    • Group 1: 44.5 ± 13.7

    • Group 2: 49.8 ± 11.9

  • Number (group 1/group 2):138 (70/68)

  • Sex (M/F)

    • Group 1: 37/33

    • Group 2: 42/23

  • Exclusions: Human leukocyte antigen (HLA)‐identical donor; third or subsequent transplant; previously transplanted with another organ other than kidney; multiple organ transplants

Interventions Treatment group 1
  • Basiliximab: 20 mg days 0 and 4


Treatment Group 2
  • ATG (ATGAM): 15 mg/kg/d with 48 hrs for up to 14 days


Baseline immunosuppression
  • CSA: Initial dose 3‐5 mg/kg and dose then adjusted to therapeutic trough (NS)

  • MMF: 2‐3 g/d for minimum of 12 months

  • Steroids: 0.5‐1.0 g day 1 then tapered to 20 mg/d by day 28 and then maintained between 5‐15 mg/d

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Infection/CMV

  • Delayed graft function

  • Adverse reaction

  • Malignancy

Notes
  • 1 year follow‐up

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated "randomised", no further information provided
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias) 
 Objective outcomes High risk Open label, blinding of outcome assessors not stated
Blinding (performance bias and detection bias) 
 Subjective outcomes High risk Open label, blinding of outcome assessors not stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk Not ITT. Six patients excluded: 3 did not receive treatment, 2 withdrew consent and 1 lost to follow‐up ‐ all for ATG group
Selective reporting (reporting bias) Low risk Primary outcomes for this review (death, graft loss and acute rejection) have been reported
Other bias High risk "Supported by Novartis Pharmaceuticals", one author an employee of Novartis