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

Nematalla 2007.

Methods
  • Study design: parallel RCT

  • Time frame: 2004 to 2005

  • Follow‐up period: 1 year

  • Primary endpoint: incidence of biopsy‐proven acute rejection within 12 months after transplantation

Participants
  • Country: Egypt

  • Setting: single centre

  • First living kidney transplant; recipient age 22 to 56 years; donor age 21 to 60 years

  • Number (randomised/analysed): withdrawal group (50/50); maintenance group (50/50)

  • Mean age ± SD (years): withdrawal group (30 ± 11); maintenance group (29 ± 10)

  • Sex (female): withdrawal group (20%); maintenance group (36%)

  • Exclusion criteria: mismatch at HLA‐DR locus

Interventions Treatment group
  • Steroid withdrawal day 4 after transplantation (if TAC levels in target range)


Control group
  • Steroid maintenance


Baseline immunosuppression
  • Basiliximab: day 0 and 4: 20 mg

  • TAC: starting on day ‐2 with 0.1 mg/kg/d adjusted to trough levels week 1 to 2: 10‐15 ng/mL; thereafter: 5 to 10 ng/mL

  • MMF: week 1 to 2: 1000 mg twice daily; thereafter 750 mg twice daily

  • Steroids

    • IV methylprednisone: day 0: 500 mg

    • Withdrawal group: methylprednisone: day 1: 500 mg; day 2: 250 mg; day 3: 100 mg; thereafter no further steroids

    • Maintenance group: methylprednisone: day 1, 3, 7, 14: 3.5 mg/kg/d; followed by gradual tapering to 0.15 mg/kg/d by month 9

Outcomes
  • Mortality

  • Graft loss

  • Biopsy‐proven acute rejection

  • NODAT

  • Infection

  • CMV infection

  • SCr (µmol/L)

  • eGFR (mL/min)

Notes
  • Did not report number screened for eligibility

  • Contact with study authors for additional information: authors contacted 9 July 2013; no response received

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk '100 similar closed opaque envelopes were made, each containing a slip of opaque paper with the type of maintenance immunosuppression. Therefore, 50 envelopes were with steroid and the rest were without. All envelopes were kept closed until the morning of the transplant day, when one envelope was selected for each patient'.
Allocation concealment (selection bias) Low risk 'Similar closed opaque envelopes, each containing a slip of opaque paper'.
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; number of patients in groups varies slightly between reports
Selective reporting (reporting bias) Low risk Primary outcomes for this review reported
Other bias Unclear risk Different protocol between groups for steroid dosing before withdrawal
Funding source not reported