A Phase 2a, Randomized, Placebo-controlled, Single Center Trial to Evaluate the Impact of Intravenous Bendavia™ (MTP-131) on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery (PTRA)
Trial status: Open for Enrollment
Why is this study being done?
The primary objective of this trial is to assess the effects of Bendavia on renal blood flow and renal function in atherosclerotic renal artery stenosis (ARAS), compared with placebo in patients with ARAS who receive one dose of study drug infused 30 minutes before and 3 hours after percutaneous transluminal angioplasty of the renal artery (PTRA).
Who is eligible to participate?
- ≥40 and ≤80 years old.
- Patients with hypertension (Systolic Blood Pressure >155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) for two weeks prior to study. 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
- 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.