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The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem | All patients were followed up during 2 years after Dotarem administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Desché, MD | Guerbet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covenant Health Care | Saginaw | Michigan | United States | |||
| St. Louis University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Included Patients | All patients included in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2012 | Sep 6, 2018 |
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| St Louis |
| Missouri |
| United States |
| Abington Memorial Hospital | Philadelphia | Pennsylvania | United States |
| University of Texas Health Science Center | San Antonio | Texas | United States |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| UZ Brussel | Brussels | Belgium |
| AZ St Lucas | Ghent | Belgium |
| H. Hartziekenhuis | Roeselare | Belgium |
| Hospital Universitario de San Ignacio | Bogotá | Colombia |
| IATM (Instituto de alta tecnologia Medica de Antoquia) | MedellÃn | Colombia |
| Hôpital Necker - Enfants malades | Paris | France |
| Hôpital Bois-Guillaume - CHU de Rouen | Rouen | France |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| Institute of Radiology and Neuroradiology | Frankfurt | Germany |
| Instituto Tumori Pascale | Naples | Italy |
| Ospedale Santa Maria | Pozzuoli | Italy |
| Universita campus Biomedico | Roma | Italy |
| Soonchunhyang Univ. Bucheon Hospital | Gyeonggi-do | South Korea |
| Uijeongbu St. Mary's Hospital | Gyeonggi-do | South Korea |
| Chung-Ang Univ. Medical Center | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Hospital ClÃnico San Carlos de Madrid | Madrid | Spain |
| CRC Hospital Universitari Sant Joan de Reus | Reus | Spain |
| Dişkapi Etlik Polikliniği | Ankara | Turkey (Türkiye) |
| Medeniyet University Goztepe Research and Training Hospital | Istanbul | Turkey (Türkiye) |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| University Hospital of North Staffodshire | Stoke-on-Trent | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | The safety population included all patients receiving at least one injection of contrast media regardless of the quantity. |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem | Posted | Count of Participants | Participants | All patients were followed up during 2 years after Dotarem administration. |
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The collection of adverse events was done during the MRI examination and during the usual follow-up post-contrast agent administration (mainly less than 30 minutes post-injection).
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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 | Safety Population | The safety population included all patients receiving at least one injection of contrast media regardless of the quantity. | 0 | 539 | 0 | 539 | 0 | 539 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, Head of Clinical Projects and Medical Writing | Guerbet | +33(0)1 45 91 50 00 | corinne.dubourdieu@guerbet.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2018 | Sep 6, 2018 | SAP_001.pdf |
| 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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| Argentina |
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| Turkey |
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| Belgium |
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| United States |
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| Italy |
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| United Kingdom |
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| France |
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| Germany |
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| Spain |
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