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. 2016 Aug 22;2016(8):CD005632. doi: 10.1002/14651858.CD005632.pub3

FREEDOM Study 2008.

Methods

  • Study design: parallel RCT

  • Time frame: 2001 to 2005

  • Follow‐up period: 1 year

  • Primary endpoint: eGFR at 1 year post‐transplant
Participants

  • Country: North America, South Africa, Europe, Australia, Asia

  • Setting: multicentre (40 centres)

  • First cadaveric or living kidney transplantation; aged 18 to 75 years

  • Number (randomised/analysed): treatment group 1 (112/111); treatment group 2 (116/115); control group (109/109)

  • Mean age ± SD (years): treatment group 1 (43 ± 13); treatment group 2 (46 ± 12); control group (47 ± 13)

  • Sex (female): treatment group 1 (35%); treatment group 2 (27%); control group (36%)

  • Donor source (living donor)

  • Treatment group 1 (48%); treatment group 2 (30%); control group (41%)

  • Exclusion criteria: donor age > 60 years; non heart beating donor; previous organ transplant; current PRA > 20%; cold ischaemia time > 24 h
Interventions Treatment group 1

  • No steroids at any time


Treatment group 2

  • Steroid withdrawal day 7 after transplantation


Control group

  • Steroid maintenance


Baseline immunosuppression

  • Basiliximab: day 0 and 4: 20 mg

  • CsA: starting within 24 h of transplantation with 10 mg/kg/d adjusted to C2 levels month 1: 1500 to 2000 ng/mL; month 2: 1300 to 1700 ng/mL; month 3: 1100 to 1500 ng/mL; month 4 to 6: 900 to 1300 ng/mL; thereafter: 800 to 1000 ng/mL

  • EC‐MPS: day 0: 720 to 1440 mg; thereafter 1440 mg/day divided in two doses

  • Steroids (for treatment group 2 and control group)

    • IV methyl prednisone: day 0: 500 mg; day 1: 250 mg; day 2: 125 mg

    • Oral prednisolone: day 3: 60 mg; day 4: 40 mg; day 5: 30 mg; day 6: 20 mg

    • Treatment group 2: no further steroids

    • Control group: month 1: 10 to 30 mg; month 2: 10 to 20 mg; thereafter: 5 to 10 mg
Outcomes

  • Mortality

  • Graft loss

  • Biopsy‐proven acute rejection

  • NODAT

  • Infection

  • CMV infection

  • Malignancy

  • CrCl (mL/min)

  • SCr (mg/dL)
Notes

  • Did not report number screened for eligibility

  • Number of patients excluded from analysis

    • Did not undergo transplantation: treatment group 1 (1); treatment group 2 (1); control group (0)

  • Number of patients discontinued treatment: treatment group 1 (38, 25%); treatment group 2 (34, 34%); 20 patients in control group (20, 20%)

  • Number of patients discontinued study

    • Treatment group 1 (8%): loss to follow‐up (2), withdrawal of consent (2), death (5)

    • Treatment group 2 (10%):loss to follow‐up (4), withdrawal of consent (5), death (2)

    • Control group (9%): loss to follow‐up (3), withdrawal of consent (5), death (2)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stated 'Randomization was undertaken in a 1:1:1 ratio using a validated system that automates the random assignment of treatment groups to randomization numbers.'
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes are objective hard endpoints
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT analysis performed; all patients followed up or accounted for
Selective reporting (reporting bias) Low risk Primary endpoints for this review reported
Other bias High risk The study was funded by Novartis Pharma AG