Primovist / Eovist in Renally Impaired Patients

Bayer357 enrolled

Overview

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist 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 Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist 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.

Adverse events data will be reported in Adverse Events section.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

357

Conditions

Contrast Media

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient must be scheduled for Contrast enhanced magnetic resonance imaging (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 (Estimated glomerular filtration rate \[eGFR\] 30 - 59 mL/min/1.73 m\^2) to severe (eGFR \< 30 mL/min/1.73 m\^2) renal impairment. Exclusion Criteria: * Gadolinium based contrast agent (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 * History of existing NSF

Locations (47)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Jacksonville, Florida, United States

Unnamed facility

Honolulu, Hawaii, United States

Unnamed facility

Topeka, Kansas, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Outcomes

Primary Outcomes

Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information

A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.

Time frame: Up to 24 months following the administration of Primovist/Eovist

Secondary Outcomes

Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score

Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.

Time frame: Up to 24 months following the administration of Primovist/Eovist

Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)

The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.

Time frame: Immediately after Primovist/Eovist-enhanced MRI

Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection

The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.

Time frame: Immediately after Primovist/Eovist-enhanced MRI

Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation

The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.

Time frame: Immediately after Primovist/Eovist-enhanced MRI

Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization

The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.

Time frame: Immediately after Primovist/Eovist-enhanced MRI