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

Gelens 2006.

Methods

  • Design: open‐label RCT

  • Duration: not reported

  • Follow up: median follow up 9.2 months
Participants

  • Setting: single centre

  • Country: Netherlands

  • Kidney transplant recipients

  • Number (group 1/group 2/group 3): 54 (18/18/18)

  • Median age (years): group 1 (59.3); group 2 (47.6); group 3 (57.1)

  • Sex (M/F): group 1 (13/5); group 2 (12/6); group 3 (11/7)

  • Exclusions: graft from a HLA identical sibling; patients with a high immunological risk (PRA > 85%); previous graft survival < 1 year due to rejection
Interventions Treatment group 1

  • SRL: initial 3 mg/d (pre‐op and day 1); maintenance 1 mg/d (fixed dose)

  • TAC: 0.1 mg/d

  • Daclizumab: 1 mg/kg IV before reperfusion and on day 14


Treatment group 2

  • TAC: 0.1 mg/day for levels 15 to 20 g/L for weeks 1 and 2; 10 to 15 g/L for weeks 3 and 4; thereafter 5 to 8 g/L

  • MMF: 2 g/d


Treatment group 3

  • High dose SRL: initial 15 mg/d (pre‐op and day 1); maintenance 5 mg/d. Subsequent doses adjusted by trough levels target range: < 6 months, 10 to 15 µg/L; > 6 months, 5 to 10 µg/L

  • MMF: 2 g/d


Co‐interventions

  • MP: 125 mg MP day 0 and day 1
Outcomes

  • Death (all causes)

  • Graft loss censored for death

  • Graft loss or death with a functioning graft

  • Acute rejection
Notes

  • Comparisons: group 1 versus 2 (SRL vs MMF); group 3 versus 2 (SRL versus TAC)

  • Study ceased after interim analysis of 54 participants showed higher rejection rate in SRL/MMF group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk 12‐month, open label, prospective, parallel group, randomised (1‐1‐1), single‐centre study; no other information provided
Allocation concealment (selection bias) Unclear risk 12‐month, open label, prospective, parallel group, randomised (1‐1‐1), single‐centre study; no other information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcomes were death/graft loss and these unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All included patients included in analyses
Selective reporting (reporting bias) High risk Reported on death, graft loss, rejection‐free survival. Inadequate reporting of adverse effects
Other bias High risk Sponsored by Roche, Astellas (Fujisawa Beneleux)