| Methods |
Study design: parallel RCT Study duration: not reported Duration of follow‐up: 12 months |
| Participants |
Setting: multicentre (5 centres) Countries: Germany, Belgium Primary or secondary kidney transplant from a deceased‐donor, living‐related or living‐unrelated donor randomised 1 month after transplant; aged 18 to 75 years Number: treatment group (44); control group (45) Mean age ± SD (years): treatment group (45.5 ± 14.9); control group (48.7 ± 11.7) Sex (M/F): treatment group (28/16); control group (33/12) Exclusion criteria: receipt of a multiorgan transplant; PRA > 50%; severe liver disease; thrombocytopenia (< 75,000/mm3); neutropenia (< 1500 mm3); leukopenia (< 2,500 mm3); anaemia (Hb < 6 g/dL); active peptic ulcer disease |
| Interventions |
Treatment group
Reduced‐dose CsA C2 targets: 1300 to 1700 ng/mL (month 1), 1000 to 1300 ng/mL (months 2 and 3), 700 to 1000 ng/mL (months 4 to 6), 550 to 700 ng/mL (months 7 to 12)
Control group
|
| Outcomes |
Mean calculated CrCl Death Graft survival BPAR Adverse events |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Study was described as randomised, method of randomisation was not reported |
| Allocation concealment (selection bias) |
Unclear risk |
All patient outcome data reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Study design may not allow for blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patient outcome data reported |
| Selective reporting (reporting bias) |
Low risk |
prespecified outcomes reported |
| Other bias |
High risk |
Funded by Novartis |
