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

Muhlbacher 2014.

Methods

  • Study design: parallel RCT (1:1)

  • Study duration: recruitment 2000 to 2002

  • Duration of follow‐up: 12 months
Participants

  • Setting: multicentre (49 centres)

  • Country: Europe

  • Patients > 18 years with 1st or 2nd kidney allograft recipients (cadaveric, living unrelated or mismatched living‐related) randomised 1 month past‐transplant

  • Number: treatment group (178); control group (179)

  • Mean age ± SD (years): treatment group (47.4 ± 13.1); control group (46.1 ± 12.8)

  • Sex (M/F): treatment group (116/62); control group (125/54)

  • Exclusion criteria: systemic or localized infection; use of medications known to interact with SRL; multiple organ transplants; patients at high risk of rejection ; use of planned antibody induction therapy within 1 week before or at the time of the current transplant; baseline/screening fasting cholesterol level > 7.8 mmol/L; triglycerides > 4.6 mmol/L; Banff Grade 3 AR between transplantation and randomisation; steroid‐resistant rejection in the 1st month after transplantation; patients who were dialysis‐dependent; inadequate kidney function to support CsA reduction; SRL trough levels < 4 ng/mL
Interventions Treatment group

  • Reduced dose CsA trough levels: 75 to 100 ng/mL

  • SRL trough levels: 4 to 12 ng/mL

  • Steroids


Control group

  • Full dose CsA trough levels: 150 to 200 ng/mL

  • SRL trough levels: 4 to 12 ng/mL

  • Steroids
Outcomes

  • Patient survival

  • Graft survival

  • BPAR

  • SCr

  • CrCl

  • Infections

  • Hyperlipidaemia
Notes

  • Funding source: Wyeth Pharma

  • Medical writing and editorial support were funded by Pfizer.
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 High risk Interim analysis only reported
Selective reporting (reporting bias) Unclear risk Interim analysis, outcomes reported as prespecified
Other bias High risk Funded by Wyeth; interim analysis report