Recombinant human alkaline phosphatase survival trial
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury
IRAS ID
284004
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
AM-Pharma B.V.
Eudract number
2019-004625-24
Clinicaltrials.gov Identifier
117605, US IND Number
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
This study is a Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury (SA-AKI).
Sepsis is the leading cause of acute kidney injury (AKI) and a major cause of death. Patients with SA-AKI have a high mortality and morbidity and are at risk of developing chronic kidney disease (CKD). AM-Pharma B.V. is developing AP as a novel AP medicinal product, called recAP, to be used as an intravenous (IV) infusion for the treatment of SA-AKI. The Phase 3 trial based on the significant survival benefit observed in Phase 2 trials and favourable safety profile observed in the Phase 1 and Phase 2 studies.
This study will be run at NHS sites across the UK.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0977
Date of REC Opinion
30 Sep 2020
REC opinion
Further Information Favourable Opinion