check_circleStudy Completed
Fibrosis, Kidney Failure, Renal Insufficiency
Bayer Identifier:
13256
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Risk of nephrogenic systemic fibrosis (NSF) in patients with moderate renal insufficiency after the administration of Magnevist
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
2 YearsTrial summary
Enrollment Goal
168Trial Dates
November 2008 - November 2013Phase
Phase 4Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Charlottesville, 22908, United States | |
Completed | Cleveland, 44195, United States | |
Completed | Jacksonville, 32209-6595, United States | |
Completed | Pueblo, 81008, United States | |
Completed | Boston, 02114, United States | |
Completed | Danville, 17822-2001, United States | |
Completed | Stony Brook, 11790, United States | |
Completed | Baltimore, 21287, United States | |
Withdrawn | Chula Vista, 91910, United States | |
Withdrawn | New York, 10016, United States | |
Completed | Tacoma, 98321, United States | |
Completed | Houston, 77030, United States | |
Completed | Philadelphia, 19141, United States | |
Withdrawn | Topeka, 66604, United States | |
Completed | New Haven, 06520--804, United States | |
Withdrawn | Santa Rosa, 95405, United States | |
Completed | Philadelphia, 19104, United States | |
Withdrawn | Los Angeles, 90033, United States | |
Completed | Boston, 02118, United States | |
Withdrawn | Phoenix, 85008, United States | |
Completed | Honolulu, 96859, United States | |
Completed | Boston, 02215, United States | |
Completed | San Antonio, 78229, United States | |
Completed | Honolulu, 96813, United States | |
Completed | Memphis, 38104, United States | |
Completed | Brooklyn, 11219, United States |
Primary Outcome
- Number of participants who developed nephrogenic systemic fibrosis (NSF), based on diagnostically specific clinical and histopathological information-cohort analysis and full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-cohort analysis and per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Total number of participants with clinicopathological correlation of ‘NSF’ or ‘Consistent with NSF’ and subjects without biopsy developing clinical signs consistent with NSF-cohort analysis and full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Total number of participants with clinicopathological correlation of ‘NSF’ or ‘Consistent with NSF’ and subjects without biopsy developing clinical signs consistent with NSF-full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Total number of participants with clinicopathological correlation of ‘NSF’ or ‘Consistent with NSF’ and subjects without biopsy developing clinical signs consistent with NSF-cohort analysis and per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Total number of participants with clinicopathological correlation of ‘NSF’ or ‘Consistent with NSF’ and subjects without biopsy developing clinical signs consistent with NSF-per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-full analysis setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-per protocol setdate_rangeTime Frame:Up to 24 months following the administration of Magnevistenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1