Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography (CARIN)
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ClinicalTrials.gov Identifier: NCT02103959 |
Recruitment Status :
Completed
First Posted : April 4, 2014
Last Update Posted : February 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Non STEMI Unstable Angina | Drug: CMX-2043 Drug: Placebo comparator | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 361 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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) |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
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Experimental: CMX-2043 2.4 mg/Kg
Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose.
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Drug: CMX-2043
Slow bolus IV administration of CMX-2043 |
Experimental: CMX-2043 3.6 mg/kg
Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose.
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Drug: CMX-2043
Slow bolus IV administration of CMX-2043 |
Experimental: CMX-2043 2.4 mg/kg given twice
Bolus injection of investigational product given prior to the cardiac catheterization and again 24 hours after the first dose.
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Drug: CMX-2043
Slow bolus IV administration of CMX-2043 |
Placebo Comparator: Placebo comparator
Placebo comparator (PBS) given prior to cardiac catheterization and again 24 hours after the first dose.
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Drug: Placebo comparator
Slow bolus IV administration of PBS |
- Prevention of acute kidney injury (AKI). [ Time Frame: Three days ]Reduction in the incidence of AKI as determined by the KDIGO definition of AKI compared to placebo.
- Reduction in biomarkers of AKI [ Time Frame: Three days ]Reduction in renal injury as determined by renal biomarkers in the treatment groups compared to placebo.
- Trends in clinical outcomes [ Time Frame: 90 days ]Incidence of major adverse cardiac events (MACE) or major adverse kidney events (MAKE) or other clinical complications in the treatment groups compared to placebo.
- Prevention of cardiac injury in unstable angina (UA) subjects who go on to PCI. [ Time Frame: Three days ]Reduction in cardiac injury as determined by cardiac biomarkers in the treatment groups compared to placebo
- Safety monitoring [ Time Frame: 90 days ]Assessments of treatment emergent adverse events.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects at least 18 years of age.
- Subjects with acute coronary syndrome (excluding STEMI).
- Subjects undergoing coronary angiography with the possibility of going on to PCI. However, if it is known that the patient is unlikely to undergo PCI, the patient should not be enrolled.
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Subjects must meet either one of the following criteria:
- An eGFR < 45 mL/min as determined by the MDRD equation
- An eGFR < 60 mL/min as determined by the MDRD equation and at least one of the following:
i. Over 75 years of age ii. Diabetes mellitus iii. Ejection fraction less than 40% iv. Hypotension v. Congestive heart failure (NYHA stage II or higher) vi. Anemia (hemoglobin below 10 g/dL at screening)
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Female subjects must also meet any one of the following criteria:
- Surgically sterile with bilateral tubal ligation or hysterectomy
- Post-menopausal for at least one year
- If of child-bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
- Subjects free of non-cardiac acute injuries or illnesses that, in the opinion of the investigator, could put the subject at risk or obscure the interpretation of results.
- Subjects willing to undergo pre-and post-study blood and urine collection, physical exams and laboratory investigations.
- Subjects willing to provide signed written informed consent form.
Exclusion Criteria:
- Subjects undergoing elective coronary angiography (i.e., stable angina).
- Subjects with end-stage renal disease (i.e., eGFR < 15).
- Subjects with ST-elevation myocardial infarction (STEMI)
- Subjects who experienced cardiac arrest associated with the current admission which required chest compressions or cardiopulmonary resuscitation.
- Subjects who experienced a life threatening arrhythmia associated with the current admission such as ventricular fibrillation or ventricular tachycardia.
- Subjects who weigh over 125 kg.
- Subjects with an active history of psychiatric disorders likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
- Subjects with a history of alcohol or drug abuse within one year of screening.
- Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests which in the investigators opinion will interfere with the study conduct.
- Subjects with non-cardiac acute illness or injuries in which the investigator considers will increase the risk to the subject or to the study's success or which will obscure the interpretation of the results.
- Subject with chronic diseases considered by the investigator unfit for the procedure or which will increase the risk to the subject or to the study's success or which will obscure the interpretation of results.
- Subjects who are currently enrolled or who have participated in a clinical study within 30 days of screening or within 5 half-lives of another study drug, whichever is longer.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103959
Study Director: | Alan S Lader, PhD | Ischemix, LLC |
Responsible Party: | Ischemix, LLC |
ClinicalTrials.gov Identifier: | NCT02103959 |
Other Study ID Numbers: |
CMX-2043-2aK |
First Posted: | April 4, 2014 Key Record Dates |
Last Update Posted: | February 23, 2016 |
Last Verified: | June 2014 |
Angina, Unstable Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Neurologic Manifestations |