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. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Ferguson 2006.

Methods

  • Study design: parallel, 4‐arm RCT, randomised 2:2:2:1

  • Study duration: recruitment completed 9 January 2003

  • Duration of follow‐up: 1 year
Participants

  • Setting: multicentre (43 centres)

  • Countries: five continents (USA, Europe, Australia, Asia and South America)

  • Aged > 18 years, immediate post‐transplant; primary cadaveric or HLA‐mismatched living donor (related or unrelated).

  • Number: treatment group 1 (72); treatment group 2 (74); treatment group 3 (76); control group (39)

  • Mean age ± SD (years): treatment group 1 (47.4 ± 11.20); treatment group 2 (44.1 ± 12.73); treatment group 3 (43.4 ± 13.35); control group (45.5 ± 10.42)

  • Sex (M/F): treatment group 1 (49/23); treatment group 2 (49/25); treatment group 3 (43/33); control group (20/19)

  • Exclusion criteria: allograft cold ischaemia time >30 h, PRA > 50%, or an ABO‐incompatible or T‐cell crossmatch positive transplant; baseline pulse rate < 50 BPM; significant thrombocytopenia(< 75,000/mm3); leukopenia (< 2500/mm3); absolute neutrophil count < 1500/mm3, Hb < 6 g/dL; severe liver disease; patients in whom antibody induction therapy was planned or those who were treated with other immunosuppressive agents within the preceding 4 weeks
Interventions Treatment group 1

  • FTY720: 5 mg

  • Reduced dose CsA: 2 to 3 mg/kg


Treatment group 2

  • FTY720: 2.5 mg

  • Reduced dose CsA: 2 to 3 mg/kg


Treatment group 3

  • FTY720: 2.5 mg

  • Full‐dose CsA: 8 to 10 mg/kg


Control group

  • Full‐dose CsA: 8 to 10 mg/kg

  • MMF


C2 levels difference 50 to 70% between reduced and full dose group.
Outcomes

  • BPAR

  • GFR at 1 year

  • death

  • Graft loss
Notes

  • Funding source: "This study was funded by Novartis Pharma AG"
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 Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Partial blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not performed
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias High risk Funded by Novartis Pharma AG