Skip to main content
. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Andres 2009.

Methods

  • Study design: 3 arm, parallel RCT

  • Study duration: recruitment March 2002 to March 2003

  • Duration of follow‐up: 6 months
Participants

  • Setting: multicentre (17 centres)

  • Country: Spain

  • Primary and secondary cadaveric transplant recipients randomised within 24 hours post‐transplant

  • Number: treatment group 1 (38); treatment group 2 (40); treatment group 3 (39)

  • Mean age ± SD (years): treatment group 1 (56.4 ± 9.5); treatment group 2 (55.7 ± 9.5); treatment group 3 (57.7 ± 12.3)

  • Sex (M/F): treatment group 1 (23/15); treatment group 2 (26/14); treatment group 3 (24/15)

  • Multiorgan transplantation, previously transplanted with another organ; previous graft loss due to AR in 1st post‐transplant year
Interventions Treatment group 1

  • Low dose early CsA

    • CsA: 3 mg/kg administered twice daily to maintain C2 levels of 800 ng/mL (days 2 to 14), 1700 ng/mL (day 15 to month 2), 1500 ng/mL (during month 2), 1300 ng/mL (during month 3), 1100 ng/mL (month 4 to 6)


Treatment group 2

  • Normal dose early CsA

    • CsA: 5 mg/kg administered twice daily to maintain C2 levels of 1200 ng/mL (days 2 to 14), 1700 ng/mL (day 15 to month 2), 1500 ng/mL (during month 2), 1300 ng/mL (during month 3), 1100 ng/mL (month 4 to 6)


Treatment group 3

  • Normal dose delayed CsA, CsA and MMF were delayed until day 7 to 10

    • CsA: 5 mg/kg administered twice daily to maintain C2 levels of 1200 ng/mL (days 7 to 14), 1700 ng/mL (day 15 to month 2), 1500 ng/mL (during month 2), 1300 ng/mL (during month 3), 1100 ng/mL (month 4 to 6)


All groups

  • MMF: initiated on day 0 at 1 g twice/d

  • Oral PRED was started from days 1 to 3 at a maximum of 20 mg/d after pulse methyl‐PRED at maximum of 500 mg. Oral steroids were dose reduced over time and received at least 5 mg/d for the rest of the study period
Outcomes

  • Graft loss

  • Death

  • GFR

  • AR

  • Infection
Notes

  • Funding source: 1st author was an employee of Novartis, funding source not clarified

  • Contact with study authors for additional information: no

  • BPAR and clinical assessed AR reported separately
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 High risk Not reported; AR was clinical and BPAR
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Modified ITT analysis
Selective reporting (reporting bias) Low risk Prespecified outcomes reported
Other bias High risk First author employee of Novartis; funding source not clarified