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Primovist / Eovist in Renally Impaired Patients (PERI)

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.
 
ClinicalTrials.gov Identifier: NCT00908596
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : August 7, 2014
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.


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

Detailed Description:
Adverse events data will be reported in Adverse Events section.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: N/A
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.
Study Start Date : May 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


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

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00908596    
Other Study ID Numbers: 13701
2008-005867-33 ( EudraCT Number )
First Posted: May 27, 2009    Key Record Dates
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