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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005867-33 | EudraCT Number |
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Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Adverse events data will be reported in Adverse Events section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) | Experimental | Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoxetic acid disodium (Primovist, BAY86-4873) | Drug | Primovist/Eovist in approved indications at approved dosages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3. | Up to 24 months following the administration of Primovist/Eovist |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent. | Up to 24 months following the administration of Primovist/Eovist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90033 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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A total of 364 participants were enrolled. Of these, 4 were withdrawn prior to magnetic resonance imaging (MRI) already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons. Participants had to have moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] 65 mL/min/1.73 m^2 or less).
The first participant's first visit was on 21 May 2009. 35 study centers in Australia, Austria, Germany, Italy, Spain, South Korea, UK, USA, and Thailand screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist within the approved indications.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadoxetic Acid Disodium - Mild Renal Impairment | Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| FG001 | Gadoxetic Acid Disodium - Extended Moderate Renal Impairment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected. | Immediately after Primovist/Eovist-enhanced MRI |
| Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection | The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Immediately after Primovist/Eovist-enhanced MRI |
| Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation | The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Immediately after Primovist/Eovist-enhanced MRI |
| Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization | The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Immediately after Primovist/Eovist-enhanced MRI |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Honolulu | Hawaii | 96813 | United States |
| Topeka | Kansas | 66604 | United States |
| Baltimore | Maryland | 21287 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Brooklyn | New York | 11219 | United States |
| New York | New York | 10021 | United States |
| Durham | North Carolina | 27710 | United States |
| Memphis | Tennessee | 38104 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Herston | Queensland | 4029 | Australia |
| Woollongabba | Queensland | 4102 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Westmead NSW | 2145 | Australia |
| Graz | 8036 | Austria |
| Vienna | 1090 | Austria |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Stuttgart | Baden-Wurttemberg | 70376 | Germany |
| Erlangen | Bavaria | 91054 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Marburg | Hesse | 35033 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Essen | North Rhine-Westphalia | 45122 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Gera | Thuringia | 07548 | Germany |
| Rozzano | Milano | 20089 | Italy |
| Pozzuoli | Napoli | 80078 | Italy |
| Candiolo | Torino | 10060 | Italy |
| Brescia | 25123 | Italy |
| Milan | 20141 | Italy |
| Naples | 80131 | Italy |
| Palermo | 90127 | Italy |
| Pisa | 56124 | Italy |
| Busan | South Korea | 602-739 | South Korea |
| Seoul | South Korea | South Korea |
| Seoul | 138-736 | South Korea |
| Granada | Granada | 18012 | Spain |
| Bangkok | 10700 | Thailand |
| Bangkok | Thailand |
| Songkhla | 90110 | Thailand |
| Bristol | BS10 5NB | United Kingdom |
Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| FG002 | Gadoxetic Acid Disodium - Moderate Renal Impairment | Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| FG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadoxetic Acid Disodium - Mild Renal Impairment | Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| BG001 | Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| BG002 | Gadoxetic Acid Disodium - Moderate Renal Impairment | Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| BG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
| BG004 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information | A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Up to 24 months following the administration of Primovist/Eovist |
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| Secondary | Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score | Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Up to 24 months following the administration of Primovist/Eovist |
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| Secondary | Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) | The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Immediately after Primovist/Eovist-enhanced MRI |
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| Secondary | Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection | The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Immediately after Primovist/Eovist-enhanced MRI |
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| Secondary | Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation | The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Immediately after Primovist/Eovist-enhanced MRI |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization | The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected. | Full Analysis Set: all participants who were enrolled and received Primovist/Eovist | Posted | Number | Participants | Immediately after Primovist/Eovist-enhanced MRI |
|
Up to 24 months following the administration of Primovist/Eovist
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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 | Gadoxetic Acid Disodium - Mild Renal Impairment | Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. | 0 | 47 | 0 | 47 | ||
| EG001 | Gadoxetic Acid Disodium - Extended Moderate Renal Impairment | Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. | 0 | 32 | 1 | 32 | ||
| EG002 | Gadoxetic Acid Disodium - Moderate Renal Impairment | Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. | 0 | 193 | 7 | 193 | ||
| EG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. | 1 | 85 | 6 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(16.0 ) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA(16.0 ) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA(16.0 ) | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA(16.0 ) | Non-systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA(16.0 ) | Non-systematic Assessment |
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| Extremity contracture | Musculoskeletal and connective tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA(16.0 ) | Non-systematic Assessment |
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The study was stopped early since the FDA released the sponsor from completing enrollment because the NSF incidence estimate was lower than the original literature-based estimate, and since enrollment quota were not feasible.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D054989 | Nephrogenic Fibrosing Dermopathy |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
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| Male |
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| Black |
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| Hispanic |
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| Asian |
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| other |
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| OG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
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| OG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
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| OG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
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| OG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
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| OG003 | Gadoxetic Acid Disodium - Severe Renal Impairment | Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care. |
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