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.)
Sponsor:
Collaborators:
ABX-CRO
Examination Management Services Inc. (EMSI)
Covance
Quintiles
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209417
First received: August 24, 2005
Last updated: October 9, 2014
Last verified: October 2014

August 24, 2005
October 9, 2014
June 2005
May 2011   (final data collection date for primary outcome measure)
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.

Contrast-induced nephropathy up to day 3. The main secondary outcomes are changes in serum creatinine up to day 7
Complete list of historical versions of study NCT00209417 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

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.

GEHC has decided not to provide this detail

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Renal Insufficiency
  • Diabetes Mellitus
  • Drug: Iodixanol 320-Arm 1
    Other Name: Visipaque
  • Drug: Iopamidol 300-Arm 2
    Other Name: Isovue
  • Active Comparator: Iodixanol 320-Arm 1
    Iodixanol 320 mg I/mL
    Intervention: Drug: Iodixanol 320-Arm 1
  • Active Comparator: Iopamidol 300-Arm 2
    Iopamidol 300 mg I/mL
    Intervention: Drug: Iopamidol 300-Arm 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
656
July 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00209417
DXV406
Not Provided
GE Healthcare
GE Healthcare
  • ABX-CRO
  • Examination Management Services Inc. (EMSI)
  • Covance
  • Quintiles
  • Averion International Corporation
Study Director: Judith A Johnson, MS, MBA GE Healthcare
GE Healthcare
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP