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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.
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| Name | Class |
|---|---|
| ABX CRO | OTHER |
| Examination Management Services Inc. | INDUSTRY |
| Covance | INDUSTRY |
| Quintiles, Inc. |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodixanol 320-Arm 1 | Active Comparator | Iodixanol 320 mg I/mL |
|
| Iopamidol 300-Arm 2 | Active Comparator | Iopamidol 300 mg I/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol 320-Arm 1 | Drug |
|
| |
| Iopamidol 300-Arm 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination. | Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration. | Within 2, 3 and 7 days post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Johnson, MS, MBA | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States | ||
| GE Healthcare |
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656 subjects enrolled. 8 subjects did not continue on in the study. 7 of the 8 subjects discontinued the study prior to contrast media administration and 1 of the 8 subjects received a contrast media of unknown type and was excluded from the study.
Subtracting 8 subjects from the total 656, a total of 648 subjects actually completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodixanol 320-Arm 1 | Iodixanol 320 mg I/mL Iodixanol 320-Arm 1 |
| FG001 | Iopamidol 300-Arm 2 | Iopamidol 300 mg I/mL Iopamidol 300-Arm 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodixanol 320-Arm 1 | Iodixanol 320 mg I/mL Iodixanol 320-Arm 1 |
| BG001 | Iopamidol 300-Arm 2 | Iopamidol 300 mg I/mL Iopamidol 300-Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group. | Posted | Number | 95% Confidence Interval | percentage of subjects | From baseline up to 3 days post contrast administration. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodixanol 320-Arm 1 | Iodixanol 320 mg I/mL Iodixanol 320-Arm 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Gordon, PhD | GE Healthcare | 011-47-2318-5822 | Paul.Gordon@ge.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| INDUSTRY |
| Averion International Corporation | INDUSTRY |
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| Drug |
|
|
| Amersham |
| HP7 9LL |
| United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Iodixanol 320-Arm 1 | Iodixanol 320 mg I/mL Iodixanol 320-Arm 1 |
| OG001 | Iopamidol 300-Arm 2 | Iopamidol 300 mg I/mL Iopamidol 300-Arm 2 |
|
|
| Secondary | Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination. | Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration. | Posted | Number | Number of images | Within 2, 3 and 7 days post contrast administration. | Images Analyzed | Participants |
|
|
|
| 6 |
| 321 |
| 0 |
| 321 |
| EG001 | Iopamidol 300-Arm 2 | Iopamidol 300 mg I/mL Iopamidol 300-Arm 2 | 6 | 327 | 0 | 327 |
| Cardiac Failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cardiac Failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure Acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for both Iodixanol and Iopamidol. |
|
| Renal Impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for Iodixanol. |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for Iodixanol. |
|
| Sudden Death | Cardiac disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for Iopamidol. |
|
| Aortic Dissection | Cardiac disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for Iopamidol. |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blood Lactic Acid Increase | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coma | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sepsis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 14.0 | Systematic Assessment | Outcome was death for Iopamidol. |
|
| Cerebrovascular Accident | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Image Quality-Sufficient |
|
| Image Quality-Insufficient |
|