Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients
Condition: Chronic Renal Impairment; Diabetes Mellitus
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Intervention: Iopamidol injection 76%; iodixanol
Intervention description: Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution; Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)
      following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque
      320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus
      undergoing cardiac angiography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides written Informed Consent and is willing to comply with protocol requirements

          -  Is >18 years of age

          -  Has a documented predose serum creatinine level of ≥1.5 mg/dL for men and ≥1.3 mg/dL
             for women or predose eGFR of >15 and ≤50 mL/min/1.73 m2, calculated via the
             Modification of Diet in Renal Disease (MDRD) formula from a SCr obtained within 72
             hours of enrollment into the study;

          -  Diagnosed as having diabetes mellitus (Type 1 or Type 2) treated with insulin or oral
             hypoglycemic agents for at least 6 months

          -  Is referred for cardiac angiography with or without percutaneous coronary
             intervention;

          -  If at the discretion of the Investigator is receiving or will be receiving a
             prophylactic medication for renal function, the medication is one that is permitted by
             this protocol (N acetylcysteine, 1200 mg twice daily on the day before and on the day
             of the cardiac angiography procedure);

          -  Undergoes or is scheduled to undergo pre, peri, or post procedure hydration permitted
             by this protocol, i.e.:

             154 mEq/L sodium bicarbonate solution, administered intravenously at 3 mL/kg/hr for 1
             hour before cardiac angiography, followed by an infusion of 1 mL/kg/hr during and out
             to 6 hours after cardiac angiography, or 154 mEq/L sodium chloride solution (0.9%
             normal saline), administered intravenously at 1 mL/kg/hr for 8 12 hours before cardiac
             angiography, followed by an infusion of 1 mL/kg/hr during and out to 8-12 hours after
             cardiac angiography

        Exclusion Criteria:

        -Is a pregnant or lactating female. Exclude the possibility of pregnancy: by laboratory
        testing on-site at the institution (measurement of serum or urine beta human chorionic
        gonadotropin) within 24 hours prior to the start of investigational product administration
        by history (e.g., tubal ligation or hysterectomy, post menopausal with a minimum 1 year
        without menses)

          -  Has a history of hypersensitivity to iodine-containing compounds;

          -  Has unstable renal function (i.e., acute worsening of renal function, as determined by
             the Investigator, that has been observed in the 7 days prior to enrollment) and/or is
             in acute renal failure;

          -  Has stage 5 chronic kidney disease or end-stage renal disease (i.e., estimated
             glomerular filtration rate [eGFR] <15 mL/min/1.73 m2)

          -  Has severe congestive heart failure (class IV in accordance with the classification of
             the New York Heart Association (NYHA);

          -  Has uncontrolled diabetes, as determined by the Investigator;

          -  Has received an iodinated contrast agent within 7 days prior to the administration of
             the study agent or is scheduled to receive an iodinated contrast agent within 72 hours
             after administration of the study agent;

          -  Is receiving cyclo-oxygenase-2 inhibitors, nonsteroidal anti-inflammatory drugs (with
             exception of low dose aspirin [≤325 mg per day]), aminoglycosides, or any other drugs
             that carry a significant risk of nephrotoxicity (in the opinion of the Investigator)
             during the time period beginning within 72 hours prior to contrast administration and
             up to 72 hours postdose;

          -  Prior to, during or post the cardiac angiography, is receiving or will be receiving a
             prophylactic medication to prevent acute kidney injury that is not permitted by this
             protocol (e.g., theophylline, fenoldopam, etc.);

          -  During cardiac angiography, is going to receive provocative pharmacological agents
             such as adenosine or dipyridamole;

          -  Is planned to undergo major surgery (e.g. coronary artery bypass graft, valve surgery,
             etc.) within 48-72 hours after contrast administration;

          -  Is planned to receive an intravenous diuretic or mannitol as prophylaxis to prevent
             acute renal injury (Note: chronic administration is allowed);

          -  Is hemodynamically unstable within 48 hours pre-contrast administration defined as a
             systolic blood pressure <90 mmHg or requires pressor or intra-aortic balloon support;

          -  Has any medical condition or other circumstances which would significantly decrease
             the chances of obtaining reliable data, achieving study objectives, or completing the
             study and/or postdose follow-up examinations;

          -  Is determined by the Investigator that the patient is clinically unsuitable for the
             study Note: Changes in diuretics, angiotensin-converting enzyme inhibitors, or
             angiotensin receptor blockers doses within 72 hours prior to and up to 72 hours post
             contrast administration should be avoided unless clinically necessary for the
             subject's underlying medical condition.