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

CONVERT Trial 2009.

Methods

  • Study design: parallel RCT randomised 2:1; stratified according to baseline GFR

  • Study duration: recruitment 5 February 2002 to 1 March 2004

  • Duration of follow‐up: 24 months
Participants

  • Setting: multicentre (111 centres)

  • Countries: Asia, Australia, Europe, the Middle East, Canada, Mexico, United States, South Africa, Argentina, Brazil, Chile

  • Patients aged ≥ 13 years and recipients of living or deceased donor with functioning graft; received a CNI (CsA or TAC) after transplantation along with corticosteroids, and AZA (50 mg/d) or MMF (500 mg/d) for at least 12 weeks before randomisation kidney transplant 6 to 120 months before randomisation

  • Number: treatment group (555); control group (275)

  • Mean age ± SE (years): treatment group (43.7 ± 0.6); control group (42.6 ± 0.82)

  • Sex (males): treatment group (69.4%); control group (70.5%)

  • Exclusion criteria: treated for BPAR or clinically diagnosed AR within 12 weeks of enrolment
Interventions Treatment group

  • CNI ceased and SRL introduced (trough 8 to 20 ng/mL)


Control group

  • CNI group: continued CsA or TAC (CsA trough 50 to 250 ng/mL; TAC trough 4 to 10 ng/mL)


Both groups

  • AZA

  • MMF
Outcomes

  • GFR at 12 months

  • BPAR

  • Graft survival at 12 and 24 months

  • Patient survival at 12 and 24 months
Notes

  • Stratified into GFR 20 to 40 mL/min and > 40 mL/min pre randomisation

  • Study included both TAC and CsA

  • Funding source: This study was supported by Wyeth Research, Collegeville, PA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerized randomisation/enrolment system used
Allocation concealment (selection bias) Low risk Automatic transtelephonic randomisation was used to assign study treatment groups.
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 performed
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk High dropout, however ITT
Selective reporting (reporting bias) Low risk Report included all expected outcomes
Other bias High risk Funded by Wyeth Research