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

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ClinicalTrials.gov Identifier: NCT00209417
Recruitment Status : 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.)
First Posted : September 21, 2005
Results First Posted : October 10, 2014
Last Update Posted : October 17, 2014
Sponsor:
Collaborators:
ABX CRO
Examination Management Services Inc.
Covance
Quintiles, Inc.
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief 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.

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

Detailed Description:
GEHC has decided not to provide this detail
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 656 participants
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.
Study Start Date : June 2005
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


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

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
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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


Locations
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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
ABX CRO
Examination Management Services Inc.
Covance
Quintiles, Inc.
Averion International Corporation
Investigators
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Study Director: Judith A Johnson, MS, MBA GE Healthcare
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209417    
Other Study ID Numbers: DXV406
First Posted: September 21, 2005    Key Record Dates
Results First Posted: October 10, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014
Keywords provided by GE Healthcare:
Iodixanol
Iopamidol
computed tomography
Patients with pre-existing renal impairment and diabetes
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases