A Study in Sepsis Patients With Renal Failure

Phase 2 Terminated 36 enrolled AM-Pharma

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate the safety and tolerability of AP in sepsis patients with renal failure and to investigate the effect of AP on inflammatory and clinical parameters in sepsis patients with renal failure.

Timeline

Start: 2008-05
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

Stopped: “sufficient POC to switch development from bovine AP to recombinant AP”

paper There was a significant (P=0.02) difference in favor of AP treatment relative to controls for the primary outcome variable. PMID 22269279 ↗

Publications

Results Pickkers P, Heemskerk S, Schouten J, Laterre PF, Vincent JL, Beishuizen A, Jorens PG, Spapen H, Bulitta M, Peters WH, van der Hoeven JG. Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial. Crit Care. 2012 Jan 23;16(1):R14. doi: 10.1186/cc11159.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bovine Intestinal Alkaline Phosphatase	Protein / enzyme biologic	132.5 iu/kg	Intravenous