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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103959
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Ischemix, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Non STEMI Unstable Angina Drug: CMX-2043 Drug: Placebo comparator Phase 2

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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
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.
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.
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.
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.
Drug: Placebo comparator
Slow bolus IV administration of PBS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Safety monitoring [ Time Frame: 90 days ]
    Assessments of treatment emergent adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects at least 18 years of age.
  2. Subjects with acute coronary syndrome (excluding STEMI).
  3. 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.
  4. Subjects must meet either one of the following criteria:

    1. An eGFR < 45 mL/min as determined by the MDRD equation
    2. 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)

  5. Female subjects must also meet any one of the following criteria:

    1. Surgically sterile with bilateral tubal ligation or hysterectomy
    2. Post-menopausal for at least one year
    3. 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.
  6. 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.
  7. Subjects willing to undergo pre-and post-study blood and urine collection, physical exams and laboratory investigations.
  8. Subjects willing to provide signed written informed consent form.

Exclusion Criteria:

  1. Subjects undergoing elective coronary angiography (i.e., stable angina).
  2. Subjects with end-stage renal disease (i.e., eGFR < 15).
  3. Subjects with ST-elevation myocardial infarction (STEMI)
  4. Subjects who experienced cardiac arrest associated with the current admission which required chest compressions or cardiopulmonary resuscitation.
  5. Subjects who experienced a life threatening arrhythmia associated with the current admission such as ventricular fibrillation or ventricular tachycardia.
  6. Subjects who weigh over 125 kg.
  7. 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.
  8. Subjects with a history of alcohol or drug abuse within one year of screening.
  9. Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests which in the investigators opinion will interfere with the study conduct.
  10. 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.
  11. 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.
  12. 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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ischemix, LLC
Investigators
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Study Director: Alan S Lader, PhD Ischemix, LLC
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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
Additional relevant MeSH terms:
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Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations