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

Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289614

Enrollment

350

Registered

2006-02-10

Start date

2006-01-31

Completion date

2007-04-30

Last updated

2008-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Keywords

contrast induced nephropathy

Brief summary

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.

Interventions

DRUGIopamidol 370 mgI/dL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Increase in serum creatinine (SCr) at 48-72 hours post dose	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026