Primovist / Eovist in Renally Impaired Patients

NCT00908596 | Completed Phase 4 Results

• 2 other identifiers: 137012008-005867-33
• Study Type: interventional
• Target: 357
• Locations: 8 countries
• Sites: 42

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.

Conditions

Contrast Media

Keywords

Nephrogenic Systemic Fibrosis (NSF); Primovist / Eovist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

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

  Immediately after Primovist/Eovist-enhanced MRI

• Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection

  Immediately after Primovist/Eovist-enhanced MRI

• Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation

  Immediately after Primovist/Eovist-enhanced MRI

• Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization

  Immediately after Primovist/Eovist-enhanced MRI

Study Arms (1)

Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)

EXPERIMENTAL

Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.

Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Interventions

Gadoxetic acid disodium (Primovist, BAY86-4873) DRUG

Primovist/Eovist in approved indications at approved dosages

Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (47)

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Los Angeles, California, 90033, United States

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Jacksonville, Florida, 32209, United States

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Honolulu, Hawaii, 96813, United States

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Topeka, Kansas, 66604, United States

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Baltimore, Maryland, 21287, United States

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Ann Arbor, Michigan, 48109, United States

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Brooklyn, New York, 11219, United States

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New York, New York, 10021, United States

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Durham, North Carolina, 27710, United States

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Memphis, Tennessee, 38104, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Herston, Queensland, 4029, Australia

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Woollongabba, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Geelong, Victoria, 3220, Australia

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Westmead NSW, 2145, Australia

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Graz, 8036, Austria

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Vienna, 1090, Austria

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Stuttgart, Baden-Wurttemberg, 70376, Germany

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Erlangen, Bavaria, 91054, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Marburg, Hesse, 35033, Germany

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Hanover, Lower Saxony, 30625, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Dresden, Saxony, 01307, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Berlin, State of Berlin, 12200, Germany

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Gera, Thuringia, 07548, Germany

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Rozzano, Milano, 20089, Italy

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Pozzuoli, Napoli, 80078, Italy

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Candiolo, Torino, 10060, Italy

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Brescia, 25123, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Palermo, 90127, Italy

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Pisa, 56124, Italy

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Busan, South Korea, 602-739, South Korea

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Seoul, South Korea, South Korea

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Seoul, 138-736, South Korea

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Granada, Granada, 18012, Spain

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Bangkok, 10700, Thailand

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Bangkok, Thailand

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Songkhla, 90110, Thailand

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Bristol, BS10 5NB, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Nephrogenic Fibrosing Dermopathy

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was stopped early since the FDA released the sponsor from completing enrollment because the NSF incidence estimate was lower than the original literature-based estimate, and since enrollment quota were not feasible.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 23, 2015
• Results First Posted: August 7, 2014

Record last verified: 2015-07

Locations

ES (1); IT (8); US (12); KR (3); DE (12); AU (2); TH (3); GB (1)