| 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 |
