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

Bayer

Status: Completed

Conditions: Kidney Failure; Renal Insufficiency; Fibrosis

Treatments: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study type: Observational

Funder types: Industry

Identifiers

NCT00744939

13256

X312141 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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 design

168 participants in 1 patient group

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Description:

Participants received Magnevist in accordance with its labeling

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)