Safety of Gadovist in Renally Impaired Patients (GRIP)

Bayer

Status and phase: Completed; Phase 4

Conditions: Renal Impairment; Fibrosis

Treatments: Drug: Gadobutrol (Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828737

13273

2008-004496-22 (EudraCT Number)

Details and patient eligibility

About

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Enrollment: 927 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR < 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI

Exclusion criteria

• GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
• History of NSF (Nephrogenic Fibrosing Dermopathy)
• Age outside the indicated age range mentioned in national labelling.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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927 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Gadobutrol (Gadovist, BAY86-4875)