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

Frey 1991.

Methods

  • Study design: parallel RCT; patients stratified by age (18 to 49 versus ≥ 50 years), diabetes, previous transplant, graft survival if previous transplant

  • Study duration: July 1987 to September 1990

  • Study follow‐up: 2 years
Participants

  • Country: USA

  • Setting: single centre

  • Inclusion criteria: kidney and kidney‐pancreas DD transplant recipients

  • Number (kidney/kidney‐pancreas): treatment group (67/17); control group (71/18)

  • Mean age ± SD (years): treatment group (41 ± 1.3); control group (42 ± 1.3)

  • Sex (M/F): treatment group (45/39); control group (51/38)

  • Ethnicity (white): treatment group (90%); control group (93%)

  • Exclusion criteria: Initially excluded kidney transplant patients who had rejected a previous transplant in the 1st year; this was changed 1 year into the study toot include all kidney transplant recipients; kidney‐pancreas recipients excluded if > 50 years or were undergoing a retransplant of either a kidney or pancreas
Interventions Treatment group

  • OKT3: 5 mg/d for 7 days; given 1st dose in operating theatre after pre‐med with steroids


Control group

  • mALG: 20 mg/kg/d for 7 days; 1st dose 1 day post‐op; ALG continued for up to 10 days with delayed CSA start if oliguria


Immunosuppression (both groups)

  • PRED: 1 mg/kg/d, taper to 0.5 mg/kg by day 10

  • AZA: 5 mg/kg taper to 2.5 mg/kg

  • CSA: 4 mg/kg twice daily from day 5 post‐op
Outcomes

  • Death up to 2 years

  • Graft survival up to 2 years

  • Acute rejection

  • Malignancy

  • CMV infection

  • Graft function up to 2 years
Notes

  • Results reported here only for kidney transplant recipients (pancreas and kidney recipients excluded)

  • All acute rejection were biopsy‐proven acute rejection

  • Funding source: supported by NIH Research Grant 5P01‐DK 13083
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 Sealed envelopes used
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, all acute rejection was biopsy‐proven
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias Low risk Supported by NIH research grant