Trial Condition(s):
Fibrosis, Kidney Failure, Renal Insufficiency
Risk of nephrogenic systemic fibrosis (NSF) in patients with moderate renal insufficiency after the administration of Magnevist
Bayer Identifier:
13256
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients must have moderate (eGFR 30-59 ml/min/1.73 m^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.
Exclusion Criteria
- Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist - History of NSF - Clinically unstable or age <2 yrs
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32209-6595 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pueblo, United States, 81008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Danville, United States, 17822-2001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stony Brook, United States, 11790 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21287 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tacoma, United States, 98321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Haven, United States, 06520--804 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Honolulu, United States, 96859 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Honolulu, United States, 96813 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Memphis, United States, 38104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brooklyn, United States, 11219 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective non-randomized observational (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Magnevist® Injection in patients with moderate renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of participants who developed nephrogenic systemic fibrosis (NSF), based on diagnostically specific clinical and histopathological information-cohort analysis and full analysis setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-full analysis setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-cohort analysis and per protocol setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-per protocol setTimeframe: Up to 24 months following the administration of Magnevist
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 setTimeframe: Up to 24 months following the administration of Magnevist
- 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 setTimeframe: Up to 24 months following the administration of Magnevist
- 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 setTimeframe: Up to 24 months following the administration of Magnevist
- 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 setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and full analysis setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-full analysis setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and per protocol setTimeframe: Up to 24 months following the administration of Magnevist
- Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-per protocol setTimeframe: Up to 24 months following the administration of Magnevist
Additional Information
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