Dutch biopharmaceutical firm AM-Pharma has started its Phase II trial of recAP (recombinant human Alkaline Phosphatase) to treat sepsis-associated Acute Kidney Injury (AKI).
Currently, the clinical trial is underway in nine countries, and will involve around 50 sites.
The trial’s primary objective 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.
A total of 290 patients will be enrolled in the adaptive Phase II trial, which will be conducted in two-stages.
In the first stage, 120 patients will be assessed to identify and select the most effective dose out of three different doses of recap.
Under the second stage, an additional 170 patients will be enrolled in two arms of 85 patients each, who will receive either the best dose of recAP as identified in stage one, or placebo.
The company said that in both stages of the trial, the effect on kidney function during the first seven days following therapy will be measured by creatinine clearance rate, a sensitive marker of kidney function.
AM-Pharma CEO Erik van den Berg said: "The design of this trial results from close collaboration with various international experts and regulators, and builds on the previous positive Phase I data with recAP and also the Phase II data we collected in clinical trials with bovine Alkaline Phosphatase.
"It was great news therefore that the FDA approved the IND within 30 days. The adaptive trial is expected to provide essential information and clear guidance on how to progress recAP in its further development and regulatory approval."
The trial will also record the incidence and duration of renal replacement therapy (dialysis) over 28 days, and prevention of chronic kidney disease (CKD).
Apart from the kidney specific measurements, the trial will also measure non-kidney related clinical parameters such as the duration of intensive care (ICU) and hospital stay, and patient’s quality of life.