Safety of Primovist / Eovist in Renally Impaired patients

Phase 1

• Conditions: Patients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.; MedDRA version: 14.1Level: LLTClassification code 10038469Term: Renal impairment NOSSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2008-005867-33-GB
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Study Completion: 2013-07-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

•Patient must be scheduled for CE-MRI with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose 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.
•Patient must sign study-specific informed consent.
Patients are to be imaged according to the magnetic resonance (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 Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
-Rationale for selected time window: to minimize level of confounding from prior administration of GBCA for the estimation of risk of NSF for Primovist/Eovist while at the same time avoiding the elimination of too many potential participants from the study.
-Exposure to GBCA within 12 months prior to administration of Primovist/Eovist will be determined at the time of the initial evaluation via history (elicited from patient) and review of patient’s medical records, if available at that time. Subsequently, a more thorough analysis of the patient’s medical records will be carried out to ascertain the accuracy of the GBCA exposure information obtained at the time of the initial evaluation.
•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