Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

Bracco

Status and phase: Completed; Phase 4

Conditions: Kidney Diseases

Treatments: Drug: Iopamidol 370 mgI/dL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289614

IOP 105

Details and patient eligibility

About

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referred for contrast enhanced MDCT
• Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
• Diagnosed as having diabetes mellitus

Exclusion criteria

• Unstable renal function
• Unstable diabetes
• Concurrent administration of nephrotoxic drugs
• Undergoing dialysis