Primovist / Eovist in Renally Impaired Patients
Public ClinicalTrials.gov record NCT00908596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Primovist/Eovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00908596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 357 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2009
- Primary completion
- Jun 30, 2013
- Completion
- Jun 30, 2013
- Last update posted
- Jul 22, 2015
2009 – 2013
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Angeles | California | 90033 | — |
| Not listed | Jacksonville | Florida | 32209 | — |
| Not listed | Honolulu | Hawaii | 96813 | — |
| Not listed | Topeka | Kansas | 66604 | — |
| Not listed | Baltimore | Maryland | 21287 | — |
| Not listed | Ann Arbor | Michigan | 48109 | — |
| Not listed | Brooklyn | New York | 11219 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Memphis | Tennessee | 38104 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00908596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2015 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00908596 live on ClinicalTrials.gov.