At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 301 enrolled
Drug / intervention
recAP +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI
In Brief
A Phase 2 clinical trial evaluating recAP and Placebo for Acute Kidney Injury. Completed, enrolled 301 participants across 58 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury
CountriesAustria, Belgium, Czechia, Finland, France, Germany, Ireland, Netherlands, Spain, United Kingdom, United States
CollaboratorsPPD Development, LP
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartDec 2014
Primary CompletionMay 2017
Study CompletionSep 2017
TodayJul 2026
First PostedJul 8, 2014
Enrollment StartDec 18, 2014
Primary CompletionMay 25, 2017
Study CompletionSep 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.0 years ago
Interventions
recAPbiological
One hour infusions once daily for three days
Placeboother
1 hour IV infusion once daily for 3 days