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

Nagib 2015.

Methods

  • Study design: parallel RCT

  • Time frame: 2003 to 2014

  • Follow‐up period: median follow‐up was 66 ± 41 months

  • Primary endpoint: incidence of a first biopsy‐proven acute rejection (Banff type 1 or higher) within 36 months after transplantation
Participants

  • Country: Egypt

  • Setting: single centre

  • Primary kidney transplantation from living donors between 21 and 60 years of age with compatible ABO blood groups

  • Number (randomised): avoidance group (214); maintenance group (214)

  • Age range: 5 to 62 years

  • Mean age ± SD (years): avoidance group (30 ± 12); maintenance group (24 ± 13)

  • Sex (female): avoidance group (24%); maintenance group (26%)

  • Exclusion criteria: lost follow‐up; pretransplantation diabetes mellitus; other immunosuppressive protocols
Interventions Treatment group

  • Steroid avoidance on day 4


Control group

  • Steroid maintenance


Baseline immunosuppression

  • Basiliximab: days 0 and 4

  • TAC: no further information provided

  • MMF: no further information provided

  • Steroids

    • IV methylprednisone: days 0 and 1: 500 mg; day 2: 250 mg; day 3: 100 mg

    • Avoidance group: steroids stopped at day 4 provided that an acceptable TAC level was achieved

    • Maintenance group: 1.5 mg/kg/d methylprednisolone days tapered gradually to 0.15 mg/kg/d by the 9 months post‐transplantation
Outcomes

  • Mortality

  • Graft loss

  • Biopsy‐proven acute rejection

  • SCr (µmol/L)
Notes

  • Did not report number screened for eligibility or analysed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk '...patients were randomised to receive...' but no further information provided.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk Unclear if ITT analysis performed; total number of patients by group for outcomes not reported
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Funding source not reported