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Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
This study is currently recruiting participants.
Verified by GE Healthcare, November 2007
Sponsors and Collaborators: GE Healthcare
ABX-CRO
EMSI
Covance
Quintiles Laboratories
Averion-Hesperion
Information provided by: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209417
  Purpose

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 mg I/mL (Visipaque™)
Drug: iopamidol 300 mg I/mL (IsoVue)
Phase IV

MedlinePlus related topics: CT Scans Diabetes
Drug Information available for: Iodixanol Iopamidol
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Contrast-induced nephropathy up to day 3. The main secondary outcomes are changes in serum creatinine up to day 7 [ Time Frame: Incidence rate of CIN from Baseline-Day 3 ]

Estimated Enrollment: 428
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
Arms Assigned Interventions
1: Active Comparator
Iodixanol 320 mg I/mL
Drug: Iodixanol 320 mg I/mL (Visipaque™)

IMP: iodixanol 320 mg I/mL Dose: 1.5 mL/kg body weight. For subjects with a body weight exceeding 100 kilogram, a total CM volume of 150 mL should be administered.

Mode of Administration: single intravenous bolus injection at an injection rate of 4 mL/s (3 mL/s in cases of inadequate venous access).

2: Active Comparator
Iopamidol 300 mg I/mL
Drug: iopamidol 300 mg I/mL (IsoVue)

IMP: iopamidol 300 mg I/mL Dose: 1.5 mL/kg body weight. For subjects with a body weight exceeding 100 kilogram, a total CM volume of 150 mL should be administered.

Mode of Administration: single intravenous bolus injection at an injection rate of 4 mL/s (3 mL/s in cases of inadequate venous access).


Detailed Description:

GEHC has decided not to provide this detail

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209417

Contacts
Contact: Simon Cook +44 1635 254856
Contact: Jeffrey Winick 609-514-6728

Locations
United States, New Jersey
GE Healthcare Recruiting
Princeton, New Jersey, United States, 08540
Contact: Jeffrey Winick     609-514-6728        
United Kingdom
GE Healthcare Recruiting
Amersham, United Kingdom, HP7 9LL
Contact: Simon Cook     +44 1635 254856        
Sponsors and Collaborators
GE Healthcare
ABX-CRO
EMSI
Covance
Quintiles Laboratories
Averion-Hesperion
Investigators
Study Director: Judith A Johnson, MS, MBA GE Healthcare
  More Information

Study ID Numbers: DXV406
Study First Received: August 24, 2005
Last Updated: November 13, 2007
ClinicalTrials.gov Identifier: NCT00209417  
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 - French Health Products Safety Agency;   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: Drug Institute/Office for Registration of Medicinal Products, Medical Devices and Biocides

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

Study placed in the following topic categories:
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009