Primovist / Eovist in Renally Impaired Patients

Phase 4

Completed

• Conditions: Contrast Media
• Interventions: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

• Registration Number: NCT00908596
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Adverse events data will be reported in Adverse Events section.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-07-15
• Results First Submitted QC: 2014-07-15
• Results First Posted: 2014-08-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)	Gadoxetic acid disodium (Primovist, BAY86-4873)	Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information	Up to 24 months following the administration of Primovist/Eovist	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection	Immediately after Primovist/Eovist-enhanced MRI	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.
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	Up to 24 months following the administration of Primovist/Eovist	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.
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation	Immediately after Primovist/Eovist-enhanced MRI	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.
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization	Immediately after Primovist/Eovist-enhanced MRI	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.
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)	Immediately after Primovist/Eovist-enhanced MRI	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.