Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL)
An erratum to this article was published (Intensive Care Med, Apr 2024 ↗)
- stopped for futility
Authors' conclusion
Among critically ill patients with SA-AKI, ilofotase alfa did not improve day 28 survival.
Study context
- Population
- Critically ill patients with sepsis-associated AKI, enrolled < 72 h on vasopressor and < 24 h of AKI649 analysed for efficacy
- Participants
- 650 patients
- Comparison
- Ilofotase alfa vs placebo
- Ilofotase alfan = 330
- Placebon = 319reference
- Primary endpoint
- All-cause mortality
- Follow-up
- 28 days
Methodological detailsphase-3, international, double-blinded, Statistical analysis plan amended prior to unblinding, including an updated MAKE90 definition
- phase-3
- International
- Double-blinded
- Statistical analysis plan amended prior to unblinding, including an updated MAKE90 definition
Primary result
As reported in the abstract
Secondary outcomes
Mortality · 90 days
MAKE90A (main secondary endpoint)
MAKE90B (main secondary endpoint)
Days alive and free of organ support · day 28
Days alive and discharged from the ICU · day 28
- MAKE90A (main secondary endpoint): MAKE90 definition updated in amended statistical analysis plan before unblinding
Safety
Adverse events
- Adverse events: 650 analysed for safety
Original publication
Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL). Intensive Care Med. Published 3 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →