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

Hamdy 2005.

Methods
  • Design: parallel RCT

  • Duration: May 2001 to January 2003

  • Follow up: 2 years

Participants
  • Setting: Single centre study

  • Country: Egypt

  • Living donor kidney transplant recipients

  • Number (group 1/group 2): 132 (65/67)

  • Mean age ± SD (years): group 1 (32.3 ± 10.3); group 2 (31.8 ± 8.6)

  • Sex (M/F): group 1 (52/13); group 2 (47/20)

  • Exclusions: requiring 2nd kidney transplantation; patients < 18 years; cases with pre‐transplant chemistries demonstrating a total serum cholesterol > 300 mg/dL; triglycerides > than 400 mg/dL; WBC < 4000/mm3 or platelets < 150,000/mm3; pre‐transplant positive lymphocytotoxic cross‐match test; > 50% DR mismatch

Interventions Treatment group 1
  • SRL: 10 mg/d within 24 hours of transplant and for 3 days; then 5 mg/day for levels 6 to 12 ng/mL

  • TAC: 0.03 mg/kg/d started on day 3 if CrCl > 50 mL/min targeting a 12‐h whole blood trough level of 3 to 7 ng/mL.


Treatment group 2
  • SRL: 10 mg daily within 24 hours of transplant for levels of 10 to 15 ng/mL

  • MMF 2 g/d


Co‐interventions
  • Basiliximab

  • Prednisolone

Outcomes
  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • BPAR

  • GFR

  • Infection (no CMV)

  • Surgical adverse events

  • Biochemical adverse events

Notes
  • Comparison: low dose versus high dose TOR‐1

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A prospective, randomised controlled trial where they were divided into two groups"
Allocation concealment (selection bias) Unclear risk Quote: "A prospective, randomised controlled trial where they were divided into two groups"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding reported
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcomes were death and graft survival and these unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients accounted for
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias Unclear risk No report of funding