AM-Pharma B.V. has finished recruiting for its Phase II trial of treatment for individuals with Acute Kidney Injury (AKI).
The biopharmaceutical company which develops medications for inflammatory diseases, will be conducting a trial by the name of "A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients with SA-AKI."
"We are pleased to announce that we have enrolled the last patient in the STOP-AKI trial," Erik van der Berg, CEO of AM-Pharma, said. "I would like to express my appreciation to all staff in investigating ICUs for their dedication and diligence in supporting the trial."
Three-hundred and one patients were recruited, making this a record for the largest clinical study for AKI so far. The first portion of the test was completed using data from 131 patients, to determine the ideal dosage. The second portion of the test used 170 patients in which they each received either the actual medication or a placebo. To make the study even more accurate, the patients were distributed geographically throughout Western Europe and North America.
AM-Pharma was given fast track designation from the U.S. FDA in April 2016, for the use of recAP for a viable treatment of AKI.
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