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. 2019 Dec 16;2019(12):CD004290. doi: 10.1002/14651858.CD004290.pub3

Qazi 2017.

Methods

  • Design: open‐label RCT

  • Duration: January 2010 to February 2012

  • Mean Follow up: 12 months
Participants

  • Setting: multicentre (52 centres)

  • Country: USA (50); Canada (2)

  • Participants aged 18 to 70 years; kidney from a DD (including expanded criteria donor and DD after cardiac death) or living‐unrelated or related non‐HLA identical

  • Number (group 1/group 2): 613 (309/304); 3 withdrew consent from group 1

  • Mean age ± SD (years): group 1 (50.0 ± 13.3); group 2 (48.4 ± 12.9)

  • Sex (M/F): group 1 (205/101); group 2 (202/102); data did not include patients who withdrew consent

  • Exclusions: cold ischaemic time > 30 hours; ABO‐incompatible or T‐cell/B‐cell cross‐match positive transplants; recipients with platelet count < 100,000/mm3, neutrophil count < 1500/mm3, or WBC < 3000/mm3; malignancy within past 2 years; HIV, hepatitis B or C infections; other systemic infections < 30 days before transplantation
Interventions Treatment group 1

  • EVL: 1.5 mg within 24 hours; dose adjusted for target C0: 3 to 8 ng/mL from day 5

  • rTAC: C0 from day 3 onwards 4 to 7 ng/mL; 3 to 6 ng/mL at month 2; 2 to 5 ng/mL at month 6


Treatment group 2

  • MMF: 1000 mg twice/d

  • sTAC: levels from day 3 to maintain target range 8 to 12 ng/mL; 7 to 10ng/mL at month 2; 5 to 8 ng/mL at month 6


Co‐interventions

  • Prednisone

  • Ganciclovir or valganciclovir for CMV prophylaxis

  • Pneumocystic prophylaxis
Outcomes

  • Primary endpoint was composite efficacy endpoint (BPAR, graft loss, death, loss to follow‐up)

  • BPAR

  • Graft loss

  • Death

  • GFR (calculated)

  • Adverse effects

  • CMV
Notes

  • Non‐inferiority study

  • Comparison EVL versus MMF
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Novartis Drug supply Management generated a randomization list, using a validated system with a fixed‐block design that automated treatment‐arm randomization in the specified ratio'
Allocation concealment (selection bias) Low risk Investigators received treatment allocation cards with sequential randomisation numbers and treatment group information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome measures were unlikely to be influenced by lack of blinding (death, graft loss, BPAR)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Three patients only excluded from everolimus group
Selective reporting (reporting bias) Low risk Expected outcomes reported
Other bias High risk Funded by Novartis