Date: 2011-05-09
Type of information: Completion of patient enrollment
phase: 2b
Announcement: completion of the dosing
Company: Action Pharma (Denmark)
Product: AP214
Action
mechanism: AP214 is an analogue of α-melanocyte-stimulating hormone that targets both systemic inflammation and apoptosis caused by hypoxia that can occur during surgery.
Disease: protection of kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass
Therapeutic area: Renal diseases - Cardiovascular diseases - Kidney diseases
Country: Denmark, USA
Trial
details: The clinical phase IIb trial is a randomized, double-blind, placebo-controlled trial with two dose levels of AP214. A total of 78 patients were recruited in the phase IIb study at sites in Denmark and in the USA. The objectives of the study include measuring the efficacy of AP214 in preventing kidney injury and systemic inflammatory response, and on safety and tolerability levels. The trial is focused on patients undergoing cardiac surgery on cardiopulmonary bypass and with increased risk of developing kidney injury. The protocol has been designed following detailed discussions with the FDA on the AP214 clinical development program.
Latest
news: Action Pharma has completed dosing in a phase IIb clinical trial with its leading development candidate, AP214. Efficacy and safety data are expected during the third quarter of 2011. AP214 is being developed for protection of kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication.
