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

Pascual 2003.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment January 2000 to October 2001

  • Duration of follow‐up: 6 months

Participants
  • Setting: multicentre (2 centres)

  • Country: USA

  • Patients aged ≥ 18 years with stable kidney function randomised at least after 1 year post‐transplant (cadaveric, living‐related or living‐unrelated)

  • Number: treatment group (32); control group (32)

  • Mean age ± SD (years): treatment group (47 ± 12); control group (45 ± 13)

  • Sex (M/F): treatment group (27/5); control group (21/11)

  • Exclusion criteria: not reported

Interventions Treatment group
  • CsA reduction to 50% over 2 months: initial 25% reduction then further 25% reduction after 2 months if no rejection


Control group
  • CsA trough levels: 100 to 300 ng/mL


Both groups
  • MMF

  • PRED

  • CsA trough at randomisation: 100 to 300 ng/mL

Outcomes
  • Graft loss

  • AR

  • SCr

  • CrCl

  • Hypertension

Notes
  • AR: not qualified if biopsy proven or included clinical + BPAR

  • Funding source: "This work was supported by an unrestricted grant from Roche Laboratories. Manuel Pascual, MD, was supported by the Helen and George Burr Endowed Research and Educational Fund in Support of Transplantation and by the Yates Fund for Transplant Technology."

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) Unclear risk Insufficient information to permit judgement
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 No missing outcome data noted
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias High risk Funded by Roche Laboratories