NCT00744939

Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibrosis
• Kidney Failure
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Gadopentetate dimeglumine (Magnevist, BAY86-4882)	Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-07-01
• Completion: 2013-11-01
• First posted: 2008-09-01
• Last updated: 2014-09-22
• Results posted: 2014-09-22

Locations

26 sites across 1 country: United States