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Primovist / Eovist in Renally Impaired Patients (PERI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00908596
First received: May 26, 2009
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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: Primovist (Gadoxetic acid disodium, BAY86-4873)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of patients with moderate to severe renal impairment, who develop NSF, based on diagnostically specific clinical and histopathological information [ Time Frame: Within 2 years after administration of Primovist/Eovist ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist® enhanced MRI and to qualitatively assess the image quality [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ] [ Designated as safety issue: Yes ]

Enrollment: 369
Study Start Date: February 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Primovist (Gadoxetic acid disodium, BAY86-4873)
Primovist/Eovist in approved indications at approved dosages

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  • History of existing NSF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908596

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00908596     History of Changes
Other Study ID Numbers: 13701, 2008-005867-33
Study First Received: May 26, 2009
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices Korea: Food and Drug Administration
Thailand: Ministry of Public Health
United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013