At a glance
ClinicalIndex Comparison RecordN/ACompleted· 540 enrolled
Drug / intervention
Not specified
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.
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
In Brief
An observational study for Renal Insufficiency. Completed, enrolled 540 participants across 27 sites in 11 countries.
Detailed Summary
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®
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
CountriesArgentina, Belgium, Colombia, France, Germany, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedNov 2011
Primary CompletionJun 2017
TodayJul 2026
First PostedNov 8, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 14.7 years ago