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

Bracco Diagnostics, Inc350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

350

Conditions

Kidney Diseases

Interventions

Iopamidol 370 mgI/dLDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary Outcomes

Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events

Data from ClinicalTrials.gov

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