Safety of Gadovist® in Renally Impaired Patients

• Conditions: Patients with moderate to severe renal impairment.; MedDRA version: 14.1Level: LLTClassification code 10038469Term: Renal impairment NOSSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2008-004496-22-DE
• Lead Sponsor: Bayer Health Care AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-05
• Last Update Posted: 6 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient must be scheduled for CE-MRI with Gadovist based on careful risk-benefit evaluation at the recommended dose(s) in one of the approved indications.
• 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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

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 existing NSF
• Age less than 18 years
• Patients who are clinically unstable and whose clinical course is unpredictable
• Age outside the indicated age range mentioned in national labelling. (In countries where Gadovist is indicated for use in children, children are also eligible for inclusion according to national labelling).

Study & Design

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