Conditions: Renal Artery Obstruction Hypertension, Renovascular Ischemia Reperfusion Injury
Keywords: elamipretide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. arm 2: Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.

Interventions: intervention 1: Bendavia intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: