drugset / Trial / NCT02182440
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-12-18
- Primary completion
- 2017-05-25
- Completion
- 2017-09-27
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs 1.6 mg/kg (1000 U/kg) recAP; p = 0.896; Combined p-value 0.896; Inverse normal method NCT02182440 ↗
paper human recombinant alkaline phosphatase compared with placebo did not significantly improve short-term kidney function. PMID 30357272 ↗
release “While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint)” pfizer.com ↗
Publications
- Pickkers P, Mehta RL, Murray PT, Joannidis M, Molitoris BA, Kellum JA, Bachler M, Hoste EAJ, Hoiting O, Krell K, Ostermann M, Rozendaal W, Valkonen M, Brealey D, Beishuizen A, Meziani F, Murugan R, de Geus H, Payen D, van den Berg E, Arend J; STOP-AKI Investigators. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1998-2009. doi: 10.1001/jama.2018.14283.
- Peters E, Mehta RL, Murray PT, Hummel J, Joannidis M, Kellum JA, Arend J, Pickkers P. Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). BMJ Open. 2016 Sep 27;6(9):e012371. doi: 10.1136/bmjopen-2016-012371.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ilofotase Alfa | Protein / enzyme biologic | 0.4 mg/kg | Intravenous |
| Subject | Ilofotase Alfa | Protein / enzyme biologic | 0.8 mg/kg | Intravenous |
| Subject | Ilofotase Alfa | Protein / enzyme biologic | 1.6 mg/kg | Intravenous |