ClinicalTrials.Veeva

Menu

Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

General Electric (GE) logo

General Electric (GE)

Status and phase

Terminated
Phase 4

Conditions

Diabetes Mellitus
Renal Insufficiency

Treatments

Drug: Iodixanol 320-Arm 1
Drug: Iopamidol 300-Arm 2

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full description

GEHC has decided not to provide this detail

Enrollment

656 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.

Exclusion criteria

  • Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
  • Patients undergoing dialysis or kidney transplantation will not be included.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

656 participants in 2 patient groups

Iodixanol 320-Arm 1
Active Comparator group
Description:
Iodixanol 320 mg I/mL
Treatment:
Drug: Iodixanol 320-Arm 1
Iopamidol 300-Arm 2
Active Comparator group
Description:
Iopamidol 300 mg I/mL
Treatment:
Drug: Iopamidol 300-Arm 2

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems