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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

Tracking Information
First Submitted Date  ICMJE April 1, 2014
First Posted Date  ICMJE April 4, 2014
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Non STEMI
  • Unstable Angina
Intervention  ICMJE
  • Drug: CMX-2043
    Slow bolus IV administration of CMX-2043
  • Drug: Placebo comparator
    Slow bolus IV administration of PBS
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: 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.
    Intervention: Drug: CMX-2043
  • Placebo Comparator: Placebo comparator
    Placebo comparator (PBS) given prior to cardiac catheterization and again 24 hours after the first dose.
    Intervention: Drug: Placebo comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2016)
361
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2014)
265
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02103959
Other Study ID Numbers  ICMJE CMX-2043-2aK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ischemix, LLC
Study Sponsor  ICMJE Ischemix, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alan S Lader, PhD Ischemix, LLC
PRS Account Ischemix, LLC
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP