Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the … (NCT01755858) | Clinical Trial Compass
TerminatedPhase 1/2
Effects of Intravenous Bendaviaâ„¢ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
United States16 participantsStarted 2012-12
Plain-language 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).
Who can participate
Age range40 Years – 80 Years
SexALL
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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 sexu…
What they're measuring
1
Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.
Timeframe: Baseline (pre-PTRA) and 8 weeks post-PTRA