Date: 2016-04-26
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: Am-Pharma (The Netherlands)
Product: recAP - recombinant alkaline phosphatase
Action
mechanism: protein/enzyme. recAP (recombinant Alkaline Phosphatase) is a proprietary recombinant human AP constructed from two naturally occurring human isoforms of the AP enzyme. This hybrid is highly stable and active, and has been optimised for treating inflammatory conditions. It is being developed as an injectable for the treatment of acute kidney injury and hypophosphatasia, and an oral formulation for ulcerative colitis.
Disease: sepsis-associated Acute Kidney Injury (AKI)
Therapeutic area: Infectious diseases - Kidney diseases
Country: Belgium, Finland, Italy, The Netherlands, Spain, UK, USA
Trial
details: 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. (NCT02182440)
Latest
news: * On April 26, 2016, AM-Pharma announced that an independent data monitoring committee has completed its interim analysis of the first 120 patients recruited to the trial. The outcome is the selection of the best of the three doses that were investigated in the first stage of the study. In the second stage of the clinical trial, an additional 170 patients will be recruited in two arms of 85 patients each, where patients will receive either the selected recAP dose or placebo. The study is the largest to date investigating treatment of AKI, and will recruit a minimum of 290 patients in more than 70 sites across Western Europe and North America. Results from the study are expected in 2017. * On January 20, 2015, AM-Pharma announced that the company has recruited the first 3 patients into its Phase II trial of recAP in sepsis-associated Acute Kidney Injury (AKI). The clinical trial is now underway in 9 countries, and will involve 50 sites. The primary objective of the trial is to determine the most effective dose of recAP and to establish proof-of-concept in ameliorating AKI through measuring kidney function, and to confirm the favourable safety data from previous trials. The adaptive Phase II trial has two-stages and will recruit a total of 290 patients. In the first stage 120 patients will be evaluated to identify and select the most effective dose out of three different doses of recAP. In the second stage an additional 170 patients will be recruited in two arms of 85 patients each, receiving either the best dose of recAP as identified in stage one, or placebo. In both stages of the trial, the effect on kidney function during the first 7 days following therapy will be measured by creatinine clearance rate, a sensitive marker of kidney function. The trial will also record the incidence and duration of renal replacement therapy (dialysis) over 28 days, and prevention of chronic kidney disease. In addition to the kidney specific measurements, the trial will measure non-kidney related clinical parameters such as the duration of intensive care (ICU) and hospital stay, and patient’s quality of life.
