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

ATHENA 2016.

Methods

  • Design: open‐label RCT

  • Duration: December 2012 to March 2016

  • Follow up: 12 months
Participants

  • Setting: multicentre

  • Country: Germany (15 sites); France (12 sites)

  • Kidney transplant recipients (first or second LD or DD)

  • Number (group 1/group 2/group 3): 612 (208/199/205)

  • Mean age ± SD (years): group 1 (54.3 ± 13.5); group 2 (55.1 ± 12.6); group 3 (55.3 ± 12.1)

  • Gender (M/F): group 1 (138/70); group 2 (133/66): group 3 (140/65)

  • Exclusions: ABO‐incompatible transplant; pre‐existing donor‐specific antibodies; cold ischaemia time ≥ 30 hours; multi‐organ transplant; PRA > 20%; malignancy in previous 5 years (except skin, kidney, thyroid); pregnant/nursing mother or refusal to take contraception; thrombocytopenia; leucopenia; uncontrolled hypercholesterolaemia; hypertriglyceridaemia
Interventions Treatment group 1 (EVL/TAC)

  • EVL: C0 target: 3 to 8 ng/mL (M1 to M12)

  • TAC: 4 to 8 ng/mL (M1 to M3); 3 to 5 ng/mL (M3 to M5)


Treatment group 2 (EVL/CSA)

  • EVL: C0 target: 3 to 8 ng/mL (M1 to M12)

  • CSA: 75 to 125 ng/mL (M1 to M3); 50 to 100 ng/mL (M3 to M12)


Treatment group 3 (MPA/TAC)

  • TAC: 4 to 8 ng/mL (M1 to M3); 3 to 5 ng/mL (M3 to M5)

  • MPA: 1.44 g/d mycophenolate sodium or 2 g/d of MMF


Co‐interventions

  • Corticosteroids/basiliximab in each group
Outcomes

  • Death (all causes)

  • Graft loss

  • BPAR

  • Infections: CMV, BK

  • Adverse events
Notes

  • Comparisons: TOR‐I versus antimetabolite
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "validated system to ensure an unbiased treatment assignment in a 1:1:1 ratio"
Allocation concealment (selection bias) Unclear risk Quote: "validated system to ensure an unbiased treatment assignment in a 1:1:1 ratio"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome is GFR and unlikely to be influenced by blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 655 randomised; 43 did not receive medication. ITT population 612/safety population 612
Selective reporting (reporting bias) Low risk Expected outcomes were reported
Other bias High risk The study was funded by Novartis Pharma GmbH, Nürnberg, Germany