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Sponsors and Collaborators: |
GE Healthcare ABX-CRO EMSI Covance Quintiles Laboratories Averion-Hesperion |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00209417 |
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 |
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Renal Insufficiency Diabetes Mellitus |
Drug: Iodixanol 320 mg I/mL (Visipaque™) Drug: iopamidol 300 mg I/mL (IsoVue) |
Phase IV |
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. |
Estimated Enrollment: | 428 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Iodixanol 320 mg I/mL
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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
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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). |
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:
Exclusion Criteria:
Contact: Simon Cook | +44 1635 254856 | |
Contact: Jeffrey Winick | 609-514-6728 |
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 |
Study Director: | Judith A Johnson, MS, MBA | GE Healthcare |
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 |
Iodixanol Iopamidol computed tomography Patients with pre-existing renal impairment and diabetes |
Renal Insufficiency Metabolic Diseases Urologic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders |