NCT00209417|TerminatedPhase 4Results
Study Stopped
Supported by preliminary interim analysis. Not based on any safety signals in study or any quality issues that could affect efficacy of the product.
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Supported by preliminary interim analysis. Not based on any safety signals in study or any quality issues that could affect efficacy of the product.
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
Sponsor study identifier
interventional
656
2 countries
2
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
July 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 24, 2005
Actual (reported)September 21, 2005
Actual (reported)May 2011
Actual (reported)July 2011
Actual (reported)October 10, 2014
Actual (reported)Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
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.
From baseline up to 3 days post contrast administration.
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Within 2, 3 and 7 days post contrast administration.
Iodixanol 320 mg I/mL
Iopamidol 300 mg I/mL
GE Healthcare
Princeton, New Jersey, 08540, United States
GE Healthcare
Amersham, HP7 9LL, United Kingdom
Judith A Johnson, MS, MBA
GE Healthcare
656 participants (actual enrollment reported by the registry).
First Submitted
August 24, 2005
First Posted
September 21, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
October 17, 2014
Results First Posted
October 10, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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