Studenik 2005.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: 13 months (range: 2 to 23) Study duration: not reported Language: English Type of information: abstract Judgement on quality: unclear risk |
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| Participants | Setting: Brno, Czech Republic Allocation of participants: 39 participants, 19 allocated to Intervention A, 20 allocated to Intervention B Sex ratio: total: not reported Intervention A: not reported Intervention B: not reported Mean age: total: not reported Intervention A: not reported Intervention B: not reported Indication (no. (%)): not reported Type of donor: not reported Inclusion criteria: not reported Exclusion criteria: not reported Other: baseline characteristics reported as comparable |
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| Interventions | Intervention A: no intervention Intervention B: 9‐month glucocorticosteroid taper (dose, duration and type of glucocorticosteroid medication not reported) Concomitant immunosuppression: Tacrolimus: dose and duration not reported Mycophenolate mofetil: dose and duration not reported Hydrocortisone: 500 mg intraoperatively Daclizumab: 1 mg/kg intraoperatively then 1 mg/kg 2 to 7 days later depending on initial dose effect on CD25 expression on peripheral T‐lymphocytes |
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| Outcomes | Mortality, graft loss, acute rejection, hypertension, diabetes mellitus, CMV infection, leucopenia and CD25 expression on peripheral T lymphocytes | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: Generation of randomisation sequence not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Blinding of participants and medical staff not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Blinding of outcome assessors not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: Number of withdrawals and reasons for withdrawal not reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: Study protocol not available and results only published in abstract |
| Other bias | Unclear risk | Comment: No sample size calculation reported |
| Free of early stopping? | Unclear risk | Comment: Study only published in abstract |
| Free of baseline imbalance? | Low risk | Quote from the publication: "Both groups were comparable in all observed indicators." Comment: Study is reported as being free from baseline imbalance |