Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00908596 · ClinicalTrials.gov registry record · Phase 4
Primovist / Eovist in Renally Impaired Patients
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 357
- Enrollment target
NCT00908596: Completed Phase 4 study, sponsored by Bayer.
NCT00908596 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 357 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00908596, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 357 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Gadoxetic acid disodium (Primovist, BAY86-4873)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
What the finished NCT00908596 record still lists
NCT00908596 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 1 intervention - of which Gadoxetic acid disodium (Primovist, BAY86-4873) is the first listed.
NCT00908596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00908596 about?
NCT00908596 is a clinical study titled "Primovist / Eovist in Renally Impaired Patients". 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 potent...
What is the current status of trial NCT00908596?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 357 participants. The study started on 2009-05. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00908596?
The interventions under investigation include: Gadoxetic acid disodium (Primovist, BAY86-4873) (DRUG).
Who is sponsoring clinical trial NCT00908596?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00908596's enrollment target sits among peer trials
357 228th of 2000 higher than 1,773 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06062888 · 357 participants · Phase 2
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
- NCT06109766 · 357 participants · NA
Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth
- NCT06231342 · 357 participants · NA
Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
- NCT06533826 · 357 participants · Phase 2
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia