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Iodinated Contrast Media

Iopamidol 300-Arm 2 for Diabetes

Phase 4
Waitlist Available
Research Sponsored by GE Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2, 3 and 7 days post contrast administration.
Awards & highlights

Summary

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Eligible Conditions
  • Diabetes
  • Kidney Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2, 3 and 7 days post contrast administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2, 3 and 7 days post contrast administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
Secondary study objectives
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.

Trial Design

2Treatment groups
Active Control
Group I: Iopamidol 300-Arm 2Active Control1 Intervention
Iopamidol 300 mg I/mL
Group II: Iodixanol 320-Arm 1Active Control1 Intervention
Iodixanol 320 mg I/mL

Find a Location

Who is running the clinical trial?

Examination Management Services Inc.Industry Sponsor
ABX CROOTHER
5 Previous Clinical Trials
1,055 Total Patients Enrolled
GE HealthcareLead Sponsor
295 Previous Clinical Trials
632,910 Total Patients Enrolled
~32 spots leftby Sep 2025