NCT02103959

Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography

A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Ischemix, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. This study will specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary angiography. The study will also examine the ability of CMX 2043 for prevention of periprocedural cardiac injury. Information will be obtained relating to the ability of CMX 2043 for prevention of major adverse cardiac and renal events following the procedure. Additional information will be obtained in this study to evaluate safety of the drug. Dose and regimen information will also be obtained for future clinical studies of CMX-2043.

Conditions

• Non STEMI
• Unstable Angina

Interventions

Type	Name	Description
DRUG	CMX-2043	Slow bolus IV administration of CMX-2043
DRUG	Placebo comparator	Slow bolus IV administration of PBS

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-04-04
• Last updated: 2016-02-23