Diabetes Mellitus Clinical Trial
Official title:
RECARE (REnal Safety Following the Intra-Arterial Administration of Iopamidol vs. Iodixanol During Coronary AngiogRaphy in DiabEtic Patients)
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
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