Saftey of Primovist/Eovist in Renally Impaired patients

• 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: 14.0Level: 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: EUCTR2008-005867-33-AT
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-25
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

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

Inclusion Criteria

•Patient must be scheduled for CE-MRI OF THE LIVER 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. Patients will initially be qualified using the simplified MDRD formula, based on a determination of serum creatinine within 6 weeks prior to the administration of Primovist/Eovist. Final patient stratification will be based on the complete MDRD formula (13) based on age, gender, ethnicity; and on serum creatinine, serum urea nitrogen, and serum albumin concentration as measured within 24h prior to Primovist/Eovist administration.
•Patient must sign study-specific informed consent.

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 ÌNITIAL EVALUATION

Study & Design

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