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

Park 1994.

Methods
  • Study design: parallel RCT

  • Time frame: not reported, but before 1994

  • Follow‐up period: 1 year (6 years for 68 patients)

  • Primary endpoint: patient and graft survival rates

Participants
  • Country: Korea

  • Setting: multicentre (number of centres not reported)

  • First living kidney transplant; 18 to 65 years

  • Number (randomised): withdrawal group (141); maintenance group (153)

  • Mean age ± SD (years): not reported

  • Sex (% female): not reported

  • Exclusion criteria: SCr > 1.5 mg/dL 3 months after transplantation; active hepatitis; HBsAG seropositivity

Interventions Treatment group
  • Steroid withdrawal 3 months after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • CsA: day 0 to 2: 3 mg/kg IV; day 3: 10 mg/kg PO; reduced to 3 to 5 mg/kg/d adjusted to trough levels: month 1 to 3: 200 to 400 ng/mL; thereafter: 100 to 200 ng/mL

  • Steroids

    • IV methylprednisone: day 0: 1000 mg; day 1: 200 mg; reduced to 60 mg by day 4

    • Oral prednisone: day 5: 30 mg/d; reduced to 10 mg/d by end of month 3

      • Withdrawal group: prednisone reduced by 2.5 mg every 2 weeks until complete withdrawal 6 to 8 weeks after randomisation

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

  • NODAT

  • Infection

  • SCr (mg/dL)

  • CrCl (mL/min)

Notes
  • Did not report number screened for eligibility; randomised (294); analysed in 1998 (68)

  • Number of patients discontinued study

    • At 1 year 18 patients withdrawn from study because of regimen failure, death, graft loss, compliance, adverse events

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) 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 Unclear risk Number of patients in which the outcome was measured are not reported, survival only reported as rates; unclear if ITT analysis performed
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported
There's a substantial difference between number of participants in first published report (1994) (294) and second report (1998) (68) which is not explained