A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (STOP-AKI)
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
Sponsor: AM-Pharma
This PHASE2 trial investigates Acute Kidney Injury and is currently completed. AM-Pharma leads this study, which shows 12 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
12 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Jun 2025 — Sep 2025 [monthly]
Completed PHASE2
-
Oct 2024 — Jun 2025 [monthly]
Completed PHASE2
-
Sep 2024 — Oct 2024 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
▶ Show 7 earlier versions
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Apr 2020 — Jan 2021 [monthly]
Completed PHASE2
-
Jun 2018 — Apr 2020 [monthly]
Completed PHASE2
-
Dec 2017 — Jun 2018 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
-
Jul 2017 — Dec 2017 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Feb 2017 — Jul 2017 [monthly]
Recruiting PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Dec 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AM-Pharma
- PPD Development, LP
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
's-Hertogenbosch, Netherlands , Amsterdam, Netherlands , Angers, France , Antwerp, Belgium , Apeldoorn, Netherlands , Argenteuil, France , Badalona, Spain , Barcelona, Spain , Birmingham, United States , Brno, Czechia and 39 more locations