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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
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This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omniscan | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omniscan | Drug | OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN. | Greater than or equal to 7 days post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.
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| Name | Affiliation | Role |
|---|---|---|
| Rubin Sheng, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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There were 213 subjects enrolled in this study. Total of 202 subjects evaluated for safety purposes. Total of 153 subjects completed this study. Total of 11 subjects discontinued prior to contrast administration (no contrast media received).
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| ID | Title | Description |
|---|---|---|
| FG000 | Omniscan | OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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The 202 subjects that received contrast media were evaluated for safety.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omniscan | OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). | Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN. | Incidence of Nephrogenic Systemic Fibrosis (NSF) | Posted | Number | 95% Confidence Interval | percentage of subjects | Greater than or equal to 7 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 | Omniscan | OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician. | 7 | 202 | 0 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin burning sensation | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Skin swelling | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Muscle Weakness | Musculoskeletal and connective tissue disorders | 16.0 MedDRA | Systematic Assessment |
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| Pterygium | Eye disorders | 16.0 MedDRA | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 16.0 MedDRA | Systematic Assessment |
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| Azotemia | Renal and urinary disorders | 16.0 MedDRA | Systematic Assessment |
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As a result of the FDA reference ID: #2954949, subject enrolment was terminated at 213 subjects. All subjects (202 subjects) who received any dose of Omniscan were followed as per protocol until study completion, withdrawal, or lost-to-follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Mansfield | GE Healthcare | 609-514-6329 | debra.mansfield@ge.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C064925 | gadodiamide |
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| >=65 years |
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| China |
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| India |
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| Spain |
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| Taiwan |
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| Title | Measurements |
|---|---|
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