Ischemia Reperfusion Injury Clinical Trial
Official title:
A Phase 2a, Placebo-controlled Trial to Evaluate the Impact of Intravenous Bendavia™ on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled
study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV
elamipretide for reduction of reperfusion injury in subjects with ARAS, who are undergoing
percutaneous transluminal angioplasty of the renal artery (PTRA).
The randomization (1:1 active:placebo) was stratified by a diagnosis of diabetes mellitus.
Participants received either 0.05 mg/kg/h elamipretide or matching placebo, administered as
an IV infusion at 60 mL/h infused 30 minutes before and continued 3 hours after PTRA of the
renal artery. After completion of the PTRA and stenting, subjects were to receive standard
treatment.
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