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

Zhu 2008a.

Methods
  • Study design: parallel RCT

  • Time frame: 2003 to 2005

  • Follow‐up period: 2 years

  • Primary endpoint: not reported

Participants
  • Country: China

  • Setting: single centre

  • Cadaveric kidney transplant

  • Number (randomised): 45 total

  • Median age (range): 44 (26 to 65) years

  • Sex (% female): not reported

  • Exclusion criteria: PRA > 10%; multi‐organ transplantation; serious infections (e.g. AIDS); malignancy

Interventions Treatment group
  • Steroid withdrawal 6 months after transplantation


Control group
  • Steroid maintenance


Baseline Immunosuppression
  • TAC: day 0 to 14: adjusted to blood levels between 10 to 20 ng/mL; thereafter: 5 to 15 ng/mL

  • MMF: 1.5 to 2.0 g/d

  • Steroids

    • IV methylprednisone: day 0: 500 mg; day 1: 300mg; day 2: 200 mg

    • Oral prednisone: day 3 to 14: 20 mg/d; day 15 to 28: 15 mg/d

    • Withdrawal group: day 29 to 92: tapered to 5 mg/d; withdrawn on day 183

    • Maintenance group: day 29 to study end: 10 mg/d

Outcomes
  • Mortality

  • Acute rejection

  • NODAT

  • Infection

  • 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 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 and number of events per group not reported; unclear whether ITT analysis was performed. Number of patients lost to follow up not reported
Selective reporting (reporting bias) High risk Graft loss not reported
Other bias Unclear risk Funding source not reported
It was not reported how many of the participants were randomised to either group, whether the timing of outcome assessment is similar in all groups, whether the groups were similar at baseline, whether co‐interventions were avoided or similar
Important information on design and conduct of study not reported

ALG ‐ anti‐lymphocyte globulin; ATG ‐ anti‐thymocyte globulin; AZA ‐ azathioprine; CMV ‐ cytomegalovirus; CNI ‐ calcineurin inhibitor; CrCl ‐ creatinine clearance; CsA ‐ cyclosporin; EC‐MPS ‐ enteric‐coated mycophenolate sodium; eGFR ‐ estimated glomerular filtration rate; EVL ‐ everolimus; GFR ‐ glomerular filtration rate; HBsAG ‐ hepatitis B surface antigen; HCT ‐ haematocrit; HIV ‐ human immunodeficiency virus; HLA ‐ human leukocyte antigen; HTLV‐1 ‐ human T‐lymphotropic virus type 1; IL‐2RA ‐ interleukin 2 receptor antagonist; ITT ‐ intention‐to‐treat analysis; IV ‐ intravenous; MMF ‐ mycophenolate mofetil; NODAT ‐ new‐onset diabetes post transplant; PO ‐ oral; PRA ‐ panel reactive antibodies; PTLD ‐ Post‐transplant lymphoproliferative disease; RCT ‐ randomised controlled trial; SCr ‐ serum creatinine; SD ‐ standard deviation; SRL ‐ sirolimus; TAC ‐ tacrolimus; WCC ‐ white cell count