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.
This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with: * Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and * Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures. Approximately 10 investigative centers were to participate in this study. This study was to enroll approximately 220 patients to ensure that 200 evaluable patients were able to complete the study according to this protocol. Patients were to be randomized to receive either iopamidol-370 or iodixanol-320. Each patient was to be evaluated for the occurrence of CIN within 48 to 72 hours postdose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
23
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
Bracco Diagnostics Inc.
Princeton, New Jersey, United States
The Number of Participants With Contrast-induced Nephropathy (CIN)
The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Time frame: 48 to 72 hours After Injection of Contrast Media
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)
This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)
This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
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Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
Number of Participants Requiring Dialysis
This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.
Time frame: 48 to 72 hours after injection of contrast media
Number of Participants Who Died From Acute Renal Failure
This outcome measure provides the total number of participants who died as a result of acute renal failure.
Time frame: Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)