Primovist / Eovist in Renally Impaired Patients (PERI)

Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Primovist/Eovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.

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.

Study Overview

• Status: Completed
• Conditions: Contrast Media
• Intervention / Treatment: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Detailed Description

Adverse events data will be reported in Adverse Events section.

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Westmead NSW, Australia, 2145
  • Queensland
    • Herston, Queensland, Australia, 4029
    • Woollongabba, Queensland, Australia, 4102
  • South Australia
    • Adelaide, South Australia, Australia, 5000
  • Victoria
    • Geelong, Victoria, Australia, 3220
• Austria
  • Graz, Austria, 8036
  • Wien, Austria, 1090
• Germany
  • Berlin, Germany, 12200
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
    • Stuttgart, Baden-Württemberg, Germany, 70376
  • Bayern
    • Erlangen, Bayern, Germany, 91054
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
    • Marburg, Hessen, Germany, 35033
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44137
    • Essen, Nordrhein-Westfalen, Germany, 45122
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
  • Thüringen
    • Gera, Thüringen, Germany, 07548
• Italy
  • Brescia, Italy, 25123
  • Milano, Italy, 20141
  • Napoli, Italy, 80131
  • Palermo, Italy, 90127
  • Pisa, Italy, 56124
  • Milano
    • Rozzano, Milano, Italy, 20089
  • Napoli
    • Pozzuoli, Napoli, Italy, 80078
  • Torino
    • Candiolo, Torino, Italy, 10060
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
  • South Korea
    • Busan, South Korea, Korea, Republic of, 602-739
    • Seoul, South Korea, Korea, Republic of
• Spain
  • Granada, Spain, 18012
• Thailand
  • Bangkok, Thailand
  • Bangkok, Thailand, 10700
  • Songkhla, Thailand, 90110
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
• United States
  • California
    • Los Angeles, California, United States, 90033
  • Florida
    • Jacksonville, Florida, United States, 32209
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
  • Kansas
    • Topeka, Kansas, United States, 66604
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
  • New York
    • Brooklyn, New York, United States, 11219
    • New York, New York, United States, 10021
  • North Carolina
    • Durham, North Carolina, United States, 27710
  • Tennessee
    • Memphis, Tennessee, United States, 38104
  • Texas
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873); Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.	Drug: Gadoxetic acid disodium (Primovist, BAY86-4873); Primovist/Eovist in approved indications at approved dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months following the administration of Primovist/Eovist

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Immediately after Primovist/Eovist-enhanced MRI

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 27, 2009

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Nephrogenic Systemic Fibrosis (NSF); Primovist / Eovist
• Other Study ID Numbers: 13701; 2008-005867-33 (EudraCT Number)