Overview

Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

Status:
Terminated
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stealth BioTherapeutics Inc.
Criteria
Inclusion Criteria:

- ≥40 and ≤80 years old.

- Patients with hypertension (systolic blood pressure [BP] >155 mm Hg) and/or requiring
2 or more antihypertensive medications: no restrictions will be placed on
antihypertensive agents, although loop diuretics will be temporarily changed to
diluting site agents (eg, hydrochlorothiazide, indapamide, metolazone) prior to each
blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI) study performed
during the trial, unless, in the judgment of the Investigator, the change represents a
hazard to the patient. ARAS patients will be identified based upon radiologic and
clinical criteria suggestive of renovascular hypertension and/or hemodynamically
significant renovascular disease >60% lumen occlusion (determined by quantitative
computed tomography angiography or Doppler ultrasound velocity >200 cm/sec).

- Have an estimated glomerular filtration rate of ≥15 ml/min/1.73 m2 calculated using
the Modification of Diet in Renal Disease (MDRD) formula.

- Have no contraindications to angiography such as severe contrast allergy.

- Have no contraindications to non-contrast magnetic resonance evaluations such as a
pacemaker or magnetically active metal fragments.

- Able to comply with protocol.

- Women of childbearing age must:

- Have a negative pregnancy serum human chorionic gonadotropin test prior to receiving
study drug.

- Agree to use two forms of contraception for 3 months following receipt of the study
drug.

- Men who are sexually active and able to father a child, must agree to use one of the
birth control methods listed below for the entire study and for at least 2 months
after receiving the study drug:

- Barrier methods (such as a condom or diaphragm) used with a spermicide.

- Hormonal methods used by his partner, such as birth control pills, patches,
injections, vaginal ring, or implants.

- Intrauterine device (IUD) used by his partner.

- Abstinence (no sex).

- Competent and able to provide written informed consent

Exclusion Criteria:

- Advanced chronic kidney disease defined as either Stage 5 or end-stage renal disease
requiring dialysis.

- Have other clinically significant abnormalities or laboratory results that would, in
the opinion of the investigators, compromise the safety of the patient including
evidence of diabetic ketoacidosis, paraproteinemia, or triglycerides above 600 mg/dL.

- Clinically significant medical conditions within the six months before administration
of Bendavia (e.g., cancer, stroke, myocardial infarction, active angina, congestive
heart failure) that would, in the opinion of the investigators, compromise the safety
of the patient.

- Have received an investigational drug within thirty (30) days of baseline.

- Have a serum sodium <135 mmol/L on the day of, and prior to, the PTRA.

- Are pregnant or breast feeding.