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

Isoniemi 1990.

Methods

  • Study design: parallel RCT

  • Time frame: 1986 to 1987

  • Follow‐up period: 4 years

  • Primary endpoint: not reported
Participants

  • Country: Finland

  • Setting: single centre

  • First cadaveric kidney transplant

  • Number (randomised/analysed): withdrawal group (32/32); /maintenance group (32/29)

  • Mean age ± SD (years): withdrawal group (49 ± 13); maintenance group (47 ± 11)

  • Sex (female): withdrawal group (53%); maintenance group (38%)

  • Exclusion criteria: living donor kidney transplants; ineligibility for triple immunosuppression with CsA + AZA + steroids
Interventions Treatment group

  • Steroid withdrawal 10 weeks after transplantation


Control group

  • Steroid maintenance


Baseline immunosuppression

  • CsA: day 0: 5 mg/kg; thereafter: 10 mg/kg/d adjusted to trough levels, but no further information provided

  • AZA: day 0 to 14: 2mg/kg/d

      • Withdrawal group: from day 15: 1 mg/kg/d but temporarily increased to 2 mg/kg/d during steroid withdrawal and thereafter adjusted to WCC

      • Maintenance group: from day 15: 1 mg/kg/d

  • Steroids:

    • Methylprednisone: day 0: 1 mg/kg/d tapered in 3‐day intervals to 0.25 mg/kg by day 10

      • Withdrawal group: withdrawal over 1 to 2 weeks

      • Maintenance group: tapered to 4 to 12 mg/d during the first year
Outcomes

  • Mortality

  • Graft loss

  • Acute rejection

  • Infection

  • SCr (µmol/L)
Notes

  • Screened for eligibility: 184

  • This had two additional arms (in total 128 patients randomised)

    • Arm 3 with withdrawal of CsA (32 patients)

    • Arm 4 with withdrawal of AZA (32 patients)

  • Number of patients discontinued treatment

    • Withdrawal group: switched immunosuppression within 2 year follow‐up; AZA withdrawn (7), CsA withdrawn (3), steroids reinitiated (3)

    • Maintenance group: switched immunosuppression within 2 year follow‐up; AZA withdrawn (6), CsA withdrawn (3), steroids withdrawn (1)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated 'randomised' but no further information provided.
Allocation concealment (selection bias) Low risk Stated 'using the sealed envelope method'
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 outcomes for this review reported
Other bias Low risk 'The study was supported by a grant from the Sigrid Juselius Foundation.'
AZA dose was increased during and after steroid withdrawal in treatment group while it remained unchanged in maintenance group