At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 213 enrolled
Drug / intervention
Omniscandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.
In Brief
A Phase 4 clinical trial evaluating Omniscan for Chronic Kidney Disease and Renal Insufficiency. Completed, enrolled 213 participants across 1 site.
Detailed Summary
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Renal Insufficiency
CountriesUnited States
Collaboratorsi3 Statprobe
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionJun 2013
Study CompletionSep 2013
TodayJul 2026
First PostedMay 25, 2009
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.1 years ago
Interventions
Omniscandrug
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.