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Primovist / Eovist in Renally Impaired Patients (PERI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908596
First Posted: May 27, 2009
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose

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.


Condition Intervention Phase
Contrast Media Drug: Gadoxetic acid disodium (Primovist, BAY86-4873) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information [ Time Frame: 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:
  • 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 [ Time Frame: 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.

  • Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) [ Time Frame: 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.

  • Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection [ Time Frame: 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 "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 357
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Adverse events data will be reported in Adverse Events section.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908596


  Show 47 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00908596     History of Changes
Other Study ID Numbers: 13701
2008-005867-33 ( EudraCT Number )
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Bayer:
Nephrogenic Systemic Fibrosis (NSF)
Primovist / Eovist

Additional relevant MeSH terms:
Nephrogenic Fibrosing Dermopathy
Skin Diseases
Fibrosis
Pathologic Processes