Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Gadovist® in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information - Safety of Gadovist® in Renally Impaired Patients (the GRIP study)

Phase 1

• Conditions: Patients with moderate to severe renal impairment.; MedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency

• Registration Number: EUCTR2008-004496-22-FR
• Lead Sponsor: Bayer Health Care AG (study performed by Bayer Schering Pharma AG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-19
• Study Completion: 2015-01-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 926

Inclusion Criteria

• Patient must be scheduled for CE-MRI with Gadovist at the recommended dose(s) in one of the approved indications (for details see Appendix 1 Patient Information Leaflet of Gadovist”)
• Patient must fulfill criteria for moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe (eGFR < 30 mL/min/1.73 m2) renal impairment.
• Patients on chronic dialysis (both hemodialysis or peritoneal dialysis) will be automatically assigned to the severe” group and will not specifically require eGFR determination
• Patient must sign study-specific informed consent.

Patients are to be imaged according to the MR imaging protocols in the participating institutions, which include that physicians are to comply with the general precaution measures of MR imaging.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) within 12 months prior to administration of Gadovist
• History of existing NSF
• Age less than 18 years
• Patients who are clinically unstable and whose clinical course is unpredictable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified