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NCT00744939 · ClinicalTrials.gov registry record
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 168
- Enrollment target
NCT00744939: Completed study, sponsored by Bayer.
NCT00744939 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 168 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00744939 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 168 participants
- Enrollment target
Study Summary
Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
Primary Outcome
Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal
Interventions
- DRUG Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-11 |
What the finished NCT00744939 record still lists
NCT00744939 is an observational study that tracks outcomes without assigning an intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Gadopentetate dimeglumine (Magnevist, BAY86-4882) is the first listed.
NCT00744939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00744939 about?
NCT00744939 is a clinical study titled "Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist". Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1y...
What is the current status of trial NCT00744939?
This trial is currently completed. The enrollment target is 168 participants. The study started on 2008-11. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00744939?
The interventions under investigation include: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (DRUG).
Who is sponsoring clinical trial NCT00744939?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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