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

Kahan‐203 1999.

Methods

  • Design: single‐blind RCT (Rapamune Study Group)

  • Duration: unclear

  • Follow up: 1 year
Participants

  • Setting: multicentre study

  • Country: USA, Canada, Germany. 18 centres

  • Kidney transplant recipients; DD or unrelated LRD; 18 to 65 years

  • Number (group 1,2, 3, 4, 5, 6): 149 (25/20/27/26/24/27)

  • Mean age ± SD (years): Group 1 (42.7 ± 13.1); group 2 (43.4 ± 9.4); group 3 (47.9 ± 9.0); group 4 (42.9 ± 15.8); group 5 (44.0 ± 13.1); group 6 (44.9 ± 13.0)

  • Sex (M/F): group 1 (15/10); group 2 (14/6); group 3 (20/7); group 4 (12/14); group 5 (16/8); group 6 (15/12)

  • Exclusions: WBC ≤ 4000 mm3; Hb ≤ 70 g/L; platelets ≤ 150,000 mm3; triglycerides ≤ 4.4 mmol/L, induction with ATG/ALG
Interventions Treatment group 1

  • Placebo

  • Full dose CSA: levels 200 to 350 ng/mL initially, tapering to 200 to 300 ng/mL and then 150 to 250 ng/mL from 4 to12 months


Treatment group 2

  • SRL: 1 mg/d

  • Full dose CSA


Treatment group 3

  • SRL: 3 mg/d

  • Full dose CSA


Treatment group 4

  • SRL: 1 mg/d

  • Reduced dose CSA: levels 100 to 175 ng/mL initially, tapering to 100 to 150 ng/mL and then 75 to 125 ng/mL from 4 to 12 months


Treatment group 5

  • SRL: 3 mg/d

  • Reduced dose CSA


Treatment group 6

  • SRL: 5 mg/d

  • Reduced dose CSA


Co‐interventions

  • Prednisolone
Outcomes

  • Death (all causes)

  • Cause‐specific death

  • Acute rejection

  • SCr

  • Infection

  • CMV infection

  • Haematological adverse effects

  • Biochemical adverse effects

  • Surgical adverse effects

  • Cosmetic/life style adverse effects
Notes

  • Comparison: variable dose of TOR‐I and CNI (combine groups 2+3 and compared with 4+5+6)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Said to be randomised but no further information provided
Allocation concealment (selection bias) Unclear risk Said to be randomised but no further information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Single blind study. Patients not investigators blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcomes were death, graft survival and BPAR and these unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients appear to be accounted for; 149/151 received study drug and reported
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias High risk Sponsored by Wyeth‐Ayerst