Publications by authors named "Jacques Arend"
Article Synopsis
- Sepsis is a serious condition that can lead to acute kidney injury (AKI), but a new treatment, ilofotase alfa, shows promise in improving kidney function and reducing mortality in patients with sepsis-associated AKI.
- A phase 3 clinical trial is being conducted to further confirm the benefits of ilofotase alfa by comparing it to a placebo, involving around 1,400 participants across multiple countries.
- The trial adheres to strict ethical guidelines and will include interim evaluations to ensure safety and effectiveness, with the potential to stop early if needed.
Importance: Sepsis-associated acute kidney injury (AKI) adversely affects long-term kidney outcomes and survival. Administration of the detoxifying enzyme alkaline phosphatase may improve kidney function and survival.
Objective: To determine the optimal therapeutic dose, effect on kidney function, and adverse effects of a human recombinant alkaline phosphatase in patients who are critically ill with sepsis-associated AKI.
Introduction: Acute kidney injury (AKI) occurs in 55-60% of critically ill patients, and sepsis is the most common underlying cause. No pharmacological treatment options are licensed to treat sepsis-associated AKI (SA-AKI); only supportive renal replacement therapy (RRT) is available. One of the limited number of candidate compounds in clinical development to treat SA-AKI is alkaline phosphatase (AP).
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- The study aimed to evaluate the pharmacokinetics, safety, and tolerability of a new human recombinant alkaline phosphatase (recAP) in healthy volunteers, following promising results from prior research on its renal protective effects in sepsis-related acute kidney injury.
- Volunteers received either single or multiple doses of recAP, and the results showed that peak concentrations of recAP were reached quickly but declined rapidly, demonstrating a short half-life.
- Overall, recAP was well tolerated with no significant adverse effects or anti-drug antibodies detected, suggesting that a dosing regimen of 250 to 1000 U/kg once daily for three days is optimal for future patient trials.
Clinical trials showed renal protective effects of bovine intestinal alkaline phosphatase (AP) in patients with sepsis-associated acute kidney injury (AKI). Subsequently, a human recombinant chimeric AP (recAP) was developed as a pharmaceutically acceptable alternative. Here, we investigated the biodistribution and pharmacokinetics (PK) of recAP and developed a translational population PK model.
View Article and Find Full Text PDFCurrently there are no pharmacological therapies licensed to treat sepsis-associated acute kidney injury (AKI). Considering the high incidence and mortality of sepsis-associated AKI, there is an urgent medical need to develop effective pharmacological interventions. Two phase II clinical trials recently demonstrated beneficial effects of the enzyme alkaline phosphatase (AP).
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