Skip to main content
. 2016 Aug 22;2016(8):CD005632. doi: 10.1002/14651858.CD005632.pub3

Mericq 2013.

Methods
  • Study design: parallel RCT

  • Time frame: 2008 to 2009

  • Follow‐up period: 1 year

  • Primary endpoint: stimulation of growth after 12 months

Participants
  • Country: Chile

  • Setting: multicentre RCT (2 centres)

  • First cadaveric or living kidney transplant; < 16 years with a bone age ≤ 15 years in boys and ≤ 13 years in girls

  • Number (randomised/analysed): withdrawal group (14/12); maintenance group (16/12)

  • Mean age ± SD (years) (only reported for prepubertal patients); withdrawal group (6 ± 3); maintenance group (6 ± 4)

  • Sex (female) (only for prepubertal patients reported): withdrawal group (50%); maintenance group (42%)

  • Donor source (% living donor) not reported

  • Exclusion criteria: treatment with recombinant human growth hormone or bisphosphonate

Interventions Treatment group
  • Steroid withdrawal 6 days after transplantation


Control group
  • Steroid maintenance


Baseline immunosuppression
  • Basiliximab: days 0, 4: 20 mg/m2

  • TAC: started with 0.15 mg/kg twice daily when creatinine < 2 mg/dL; adjusted to basal levels until day 30: 10 to 15 ng/mL; thereafter: 5 to 7 ng/mL

  • MMF: until day 30: 800 mg/m2/d; day 31 to month 3: 600 mg/m2/d; thereafter: 400 mg/m2/d

  • Steroids

    • Withdrawal group: methylprednisone: day 0 to 2: 2 mg/kg/d; prednisone: day 3: 2 mg/kg/d; day 4: 1 mg/kg/d; day 5: 0.5 mg/kg/d; day 6: 0.25 mg/kg/d; then no further steroids

    • Maintenance group: methylprednisone: day 0 to 2: 2 mg/kg/d; prednisone: day 3 and 4: 2 mg/kg/d; day 5 to month 1: 1.5 mg/kg/d; reduced to 0.12 mg/kg/d until study end

Outcomes
  • Mortality

  • Graft loss

  • Acute rejection

Notes
  • Did not report number screened for eligibility

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stated 'central randomization by the principle investigator'.
Allocation concealment (selection bias) Low risk Stated 'stratified treatment allocation on the basis of block randomization carried out by a statistician who was not participating in this study using numbered containers by a computerized statistical program'.
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 Unclear whether ITT analysis performed; outcomes for prepubertal patients only reported. Number of events and per group not reported
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Low risk This study was supported by Fondecyt 1080166 (National Fund for Scientific and Technological Development)