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

Höcker 2009.

Methods

  • Study design: parallel RCT

  • Time frame: 2000 to 2006

  • Follow‐up period: 2 years

  • Primary endpoint: standardised longitudinal growth
Participants

  • Country: Germany

  • Setting: multicentre (8 centres)

  • Aged < 18 years; 12 to 24 months after first or second cadaveric or living kidney transplant; triple immunosuppression at study entry with CsA, MMF and steroids

  • Number (analysed/randomised): withdrawal group (23/23); maintenance group (19/17)

  • Mean age ± SD (years): withdrawal group (10 ± 1); maintenance group (11 ± 1)

  • Sex (female): withdrawal group (35%); maintenance group (32%)

  • Donor source (living donors): withdrawal group (22%); maintenance group (32%)

  • Exclusion criteria: irreversible acute rejection of a previous graft; PRA > 80% within 12 months before study entry; any previous steroid‐resistant acute rejection; > 2 acute rejections; biopsy‐proven acute rejection; GFR < 40 mL/min; SCr increase > 20% within the last 6 months before study entry; growth hormone therapy
Interventions Treatment group

  • Steroid withdrawal 12 to 24 months after transplantation


Control group

  • Steroid maintenance


Baseline immunosuppression

  • CsA: 5 to 10 mg/kg/d divided into 2 or 3 single doses adjusted to trough level 70 to 140 µg/L

  • MMF: 1200 mg/m2 body surface area/d, divided into two single doses

  • Steroids

    • Either prednisone 5 mg/m2/d or methylprednisolone 4 mg/m2/d

      • Withdrawal group: tapered over 12 weeks by either 0.35 mg/m2/wk or by 0.7 mg/m2/2 wk until withdrawal

      • Maintenance group: unchanged
Outcomes

  • Mortality

  • Graft loss

  • Acute rejection

  • Biopsy‐proven acute rejection

  • Infection

  • CrCl (mL/min)
Notes

  • Did not report number screened for eligibility

  • Number of patients discontinued treatment

    • Withdrawal group: switched to different immunosuppression (mTOR‐inhibitor (2), TAC (2), MMF withdrawal (1))

    • Maintenance group: withdrew MMF (1)

  • Number of patients discontinued study

    • Withdrawal group: were lost to follow‐up (2)

    • Maintenance group: withdrew consent after randomisation (2); received growth hormone (1)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stated 'central randomization by the principal investigator', stated 'block randomization stratified by pubertal status'.
Allocation concealment (selection bias) Unclear risk Stated 'concealed allocation' but not further information provided
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 Unclear risk 'Because recruitment of patients for this study was more difficult than anticipated (because some patient's parents and covering physicians had a strong bias pro or con steroid withdrawal, we performed an interim analysis, which revealed a significant difference in growth between both groups. Hence, the study was finished prematurely.'
Funding source not reported