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

Schulak 1989.

Methods
  • Study design: parallel RCT

  • Time frame: 1987 to 1989

  • Follow‐up period: 2 years

Participants
  • Country: USA

  • Setting: single centre

  • First and second cadaveric or living kidney transplant

  • Number (randomised/analysed): withdrawal group 32/32); maintenance group (35/35)

  • Mean age ± SD (years): withdrawal group (44 ± 13); maintenance group (43 ± 12)

  • Sex (female): withdrawal group (50%); maintenance group (34%)

  • Donor source (living donors): withdrawal group (16%); maintenance group (9%)

  • Exclusion criteria: previous graft lost due to rejection; ongoing steroid therapy for other diseases

Interventions Treatment group
  • Steroid withdrawal after 6 to 20 days after transplantation (most had steroids < 14 days), steroids were withdrawn shortly after CsA initiation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • ALG: 10 mg/kg day 1; 20 mg/kg day 5 to 12 depending on graft function

  • CsA: starting on last day of ALG administration with 10 mg/kg/d adjusted to blood levels between 100 to 250 ng/mL during first 3 months; tapered to 3 to 5 mg/kg/d by 6 months

  • AZA: 5 mg/kg once prior to transplantation; 1.5 to 2.0 mg/kg daily after transplantation

  • Steroids

    • IV methylprednisone: day 0: 250 mg; day 1 to 3: tapered doses

    • Oral prednisone: day 4: 1mg/kg/d; tapered to 30 mg/d by week 2; tapered to 15 mg/d at month 3 to 4

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • Infection

  • SCr (mg/dL)

Notes
  • Did not report number screened for eligibility

  • Number of patients discontinued treatment

    • Withdrawal group: returned to steroid maintenance (18)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'Patients were randomised using a table of random 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 All patients followed up or accounted for; ITT analysis performed
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Groups at baseline were different regarding gender, race and causes of kidney failure with more females, less African‐Americans, more diabetics in the steroid avoidance group
Funding source not reported