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.)
Examination Management Services Inc.
Quintiles, Inc.
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: August 24, 2005
Last updated: October 9, 2014
Last verified: October 2014
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: 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 Identifier: NCT00209417     History of Changes
Other Study ID Numbers: DXV406 
Study First Received: August 24, 2005
Results First Received: October 2, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on May 26, 2016