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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

MacDonald‐302 2001.

Methods

  • Design: parallel RCT (Rapamune Global Study Group)

  • Duration: October 1996 to September 1997

  • Follow up: 12 months
Participants

  • Setting: multicentre study (34 centres)

  • Country: Canada, USA, Australia, Italy, Sweden, France, Spain

  • Kidney transplant recipient first graft, DD or non‐HLA identical LD

  • Number (group 1/group 2/group 3): 576 (227/219/130)

  • Mean age ± SD (years): group 1 (45.6 ± 12.3); group 2 (45.1 ± 12.2)

  • Sex (M/F): group 1 (147/80); group 2 (149/70); group 3 (91/39)

  • Exclusions: systemic infection; history of cardiac abnormalities or malignancy; received an investigational agent within 4 weeks of study entry; fasting cholesterol > 9.1 mmol/L and/or fasting triglycerides > 5.6 mmol/L
Interventions Treatment group 1

  • SRL: 6 mg for one dose and then 2 mg/d


Treatment group 2

  • SRL: 15 mg for one dose and then 5 mg/d


Treatment group 3

  • Placebo


Co‐interventions

  • CSA: 12‐hour trough levels 200 to 400 ng/mL for 1 month; 200 to 300 ng/mL for months 2 and 3 then 150 to 250 ng/mL

  • Prednisolone
Outcomes

  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection

  • Steroid‐resistant rejection

  • CrCl

  • SCr

  • CMV infection

  • Malignancy

  • Haematological adverse effects

  • Biochemical adverse effects

  • Surgical adverse effects

  • Cosmetic/life style adverse effects
Notes

  • Comparison: low dose versus higher dose TOR‐I

  • Comparison: TOR‐I versus placebo/no treatment (not included in review)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients randomly assigned to one of three treatment groups in a 2:2:1 ratio. A computerized system was used to randomise and stratify patients by centre and donor source (living or cadaver)
Allocation concealment (selection bias) Low risk A computerized system was used to randomise and stratify patients by centre and donor source (living or cadaver)
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients and investigators blinded to treatment assignment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Patients and investigators blinded to treatment assignment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants accounted for
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias High risk Sponsored by Wyeth‐Ayerst