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Slow enrollment
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The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ioversol 320 mgI/mL |
|
| 2 | Active Comparator | Iodixanol 320 mgI/mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ioversol 320 mgI/mL | Drug | 125 mL of Ioversol administered in the vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Contrast-induced Nephropathy (CIN) | Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration. | Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eddie Darton, MD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35233 | United States | ||
| Radiology LTD |
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A total of 6 patients signed an informed consent for the study and therefore were considered as included
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodixanol | Patients randomized to receive Iodixanol 320 mgI/mL. |
| FG001 | Ioversol | Patients randomized to receive Ioversol 320 mgI/mL. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Iodixanol 320 mgI/mL | Drug | 125 mL of Iodixanol administered in the vein |
|
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| Tucson |
| Arizona |
| 85711 |
| United States |
| Providence Hospital | Washington D.C. | District of Columbia | 20017 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61602 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| University of Rochester Medical Center | Rochester | New York | 114642 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Radiology Consultants, Inc. | Youngstown | Ohio | 44512 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Trinity Clinic | Tyler | Texas | 75701 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IodixanoI | Patients randomized to receive iodixanol 320 mgI/mL. |
| BG001 | IoversoI | Patients randomized to receive ioversol 320 mgI/mL. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Patients With Contrast-induced Nephropathy (CIN) | Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration. | One patient from the Ioversol arm was prematurely withdrawn just after contrast medium administration due to the discovery of a new brain mass. Consequently, no SCr measurement was performed for this patient and the primary outcome could not be analyzed. | Posted | Count of Participants | Participants | Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration |
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All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.
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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 | Patients who received iodixanol 320 mgI/mL. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG001 | Ioversol | Patients who received ioversol 320 mgI/mL. | 0 | 4 | 1 | 4 | 1 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymptomatic brain mass | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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Due to the small number of patients enrolled, no statistical analyses were performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing | Guerbet | 33 (0) 1 45 91 50 00 | corinne.dubourdieu@guerbet-group.com |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C054871 | ioversol |
| C044834 | iodixanol |
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| Male |
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