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

This study has been terminated.
(Supported by preliminary interim analysis. Not based on any safety signals in study or any quality issues that could affect efficacy of the product.)
ClinicalTrials.gov Identifier:
First Posted: September 21, 2005
Last Update Posted: October 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Examination Management Services Inc.
Quintiles, Inc.
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare
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.

Condition Intervention Phase
Renal Insufficiency Diabetes Mellitus Drug: Iodixanol 320-Arm 1 Drug: Iopamidol 300-Arm 2 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function. [ Time Frame: From baseline up to 3 days post contrast administration. ]

    The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).

    Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.

Secondary Outcome Measures:
  • Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination. [ Time Frame: Within 2, 3 and 7 days post contrast administration. ]
    Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.

Enrollment: 656
Study Start Date: June 2005
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iodixanol 320-Arm 1
Iodixanol 320 mg I/mL
Drug: Iodixanol 320-Arm 1
Other Name: Visipaque
Active Comparator: Iopamidol 300-Arm 2
Iopamidol 300 mg I/mL
Drug: Iopamidol 300-Arm 2
Other Name: Isovue

Detailed Description:
GEHC has decided not to provide this detail

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209417

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
United Kingdom
GE Healthcare
Amersham, United Kingdom, HP7 9LL
Sponsors and Collaborators
GE Healthcare
Examination Management Services Inc.
Quintiles, Inc.
Averion International Corporation
Study Director: Judith A Johnson, MS, MBA GE Healthcare
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209417     History of Changes
Other Study ID Numbers: DXV406
First Submitted: August 24, 2005
First Posted: September 21, 2005
Results First Submitted: October 2, 2014
Results First Posted: October 10, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by GE Healthcare:
computed tomography
Patients with pre-existing renal impairment and diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases