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

Turcotte 1973.

Methods
  • Study design: parallel RCT, stratified by LD or DD

  • Study duration: March 1964 to November 1972

  • Study follow‐up: 18 months

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: LD (all intra‐familial) or DD kidney transplant recipients

  • Number: treatment group (36); control group (35)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • LD/DD: treatment group (17/19); control group (18/17)

  • Exclusion criteria: not reported

Interventions Treatment group
  • hATG: once/day via IM, starting 3 days pre‐op for LD or immediately pre‐transplant for DD, 3.5 mg/kg/d prior and for 7 days post‐op, 1.8 mg/kg days 8 to 21, 0.9 mg/kg days 22 to 35

  • AZA: 3 mg/kg immediately post‐op adjust as per WCC

  • PRED: 0.6 mg/kg/d for LD and 1.2 mg/kg/d for DD, by week 8 0.5 mg/kg for LD and 0.75 mg/kg for DD


Control group
  • AZA: 3 mg/kg immediately post‐op adjust as per WCC

  • PRED: double dose of treatment group, more rapid taper over 8 weeks, by week 8 0.5 mg/kg for LD and 0.75 mg/kg for DD

Outcomes
  • Patient survival

  • Graft survival

  • Graft function

  • Complications

  • Acute rejection

Notes
  • Acute rejection: reported in study but not included in the review analyses as reported as total number of acute rejection episodes (rather than total number of patients with acute rejection)

  • Infection: reported as total episodes rather than number of patients

  • Adverse reactions to ATG: all had high fevers; urticarial (9), anaphylaxis (‘mild’) (2), serum sickness (1)

  • Stopped early days 32 and 33 (2)

  • Funding source: hATG provided by Upjohn Co; Maud T. Lane Fund and research grant from Public Health Service

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Separate sets of random cards for DD and LD recipients
Allocation concealment (selection bias) Low risk Cards in sealed envelopes, not opened until the time of surgery
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, however unable to use acute rejection or infection data
Other bias Unclear risk Unclear: hATG provided by Upjohn Co (therefore partially funded by them)
Also funded by Maud T. Lane Fund and research grant from Public Health Service