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. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Chan 2008.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment May 2004 to May 2005, with the last patient visit taking place in November 2005

  • Duration of follow‐up: 6 months

Participants
  • Setting: multicentre (18 centres)

  • country: USA

  • De novo kidney transplant patients Immediately post‐transplant

  • Number: treatment group (49); control group (43)

  • Mean age ± SD (years): treatment group (47 ± 11); control group (47 ± 10)

  • Sex (M/F): treatment group (27/22); control group (30/13)

  • Exclusion criteria: multiorgan transplant or an organ from an asystolic or expanded donor criteria donor; ABO‐incompatible or T‐cell crossmatch positive transplants; PRA > 50%; recipient or donor positive for HCV or HBV

Interventions Treatment group
  • Low‐dose TAC trough levels: 4 to 7 ng/mL (months 0 to 3), 3 to 6 ng/mL (months 4 to 6)


Control group
  • Standard‐dose TAC trough levels: 8 to 11 ng/mL (months 0 to 3), 7 to 10 ng/mL (months 4 to 6)


Both groups
  • Basiliximab induction

  • EVL was initiated within 24 h of graft reperfusion at an initial dose of 1.5 mg/d, adjusted to maintain EVL trough level 3 ng/mL, a maximum trough level of 12 ng/mL was recommended

  • TAC was initiated within 24 h of graft reperfusion

  • Steroids

Outcomes
  • Kidney function at 6 months post‐transplant

  • BPAR

  • Graft loss

Notes
  • Funding source: The study was funded and supported by Novartis Pharmaceuticals Corporation. Two authors were employees of Novartis Pharmaceuticals Corporation

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Low risk Centrally generated sequential sealed treatment allocation cards
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient data reported
Selective reporting (reporting bias) Low risk Data were collected by investigators via a validated electronic system and transferred to an electronic database for analysis
Other bias High risk Funded by Novartis, USA