Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients — RECARE  

Diabetes Mellitus Clinical Trial

Official title: RECARE (REnal Safety Following the Intra-Arterial Administration of Iopamidol vs. Iodixanol During Coronary AngiogRaphy in DiabEtic Patients)

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Renal Impairment
• Diabetes Mellitus
• Renal Insufficiency
• Renal Insufficiency, Chronic

• NCT number: NCT00782639
• Study type: Interventional
• Source: Bracco Diagnostics, Inc
• Status: Terminated
• Phase: Phase 4
• Start date: March 2009
• Completion date: September 2009