A randomized, double-blind, placebo-controlled, four-arm, parallel-group, proof of concept, and dose-finding adaptive phase 2a/2b study to investigate the safety, tolerability and efficacy and effect on quality of life of human recombinant alkaline phosphatase in the treatment of patients with sepsis-associated acute kidney injury
To investigate the effect of recAP on renal function and related clinical parameters
Dose finding to support the pivotal Phase 3 program,
(and possibly serve as phase III pivotal study)
ICU patients with sepsis-associated acute kidney injury.
301 patients were enrolled in this study.
The results of this study were published in the Journal of the American Medical Association in November 2018 (full text)
Optimal dose was identified as 1.6 mg/kg.
No significant difference in short-term kidney function improvement at 7 days with recAP versus placebo.
Interesting secondary endpoint results:
- Long term kidney function improvement with recAP versus placebo.
- All-cause mortality rates at day 28 and day 90 were lower in the recAP group versus placebo
The study sponsor was AM-Pharma.