Cardiothoracic & vascular anaesthesia
A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery
Authors' conclusion
Administration of ilofotase alfa did not attenuate short- and longer-term renal function loss in patients at a high risk of renal functional impairment after on-pump cardiac surgery. No safety concerns of ilofotase alfa emerged.
Study context
- Population
- Adults at high risk of renal functional impairment (pre-existent eGFR 25–65 ml/min/1.73m2) scheduled for complex on-pump cardiac surgery204 analysed
- Participants
- 244 adults
- Comparison
- Ilofotase alfa vs placebo perioperatively
- Ilofotase alfan = 109
- Placebon = 95reference
- Primary endpoint
- Ratio of highest serum creatinine within 5 days postoperative to pre-operative level (sCrRatio)
- Follow-up
- 5 days postoperative
Methodological detailsphase 2, multicentre, double-blinded, placebo-controlled, two-arm, parallel-group
- Phase 2
- Multicentre
- Double-blinded
- Placebo-controlled
- Two-arm, parallel-group
Primary result
As reported in the abstract
sCrRatio
Ilofotase alfa
1.21
mean · SD 0.42
Placebo
1.27
mean · SD 0.50
P = 0.31
Secondary outcomes
Major adverse kidney events up to day 60 (MAKE60)
P = 0.87
Safety
- No safety concerns were raised
Original publication
A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery. Intensive Care Med. Published 21 September 2026. doi:10.
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