Trial Condition(s):
Contrast media
Primovist / Eovist in Renally Impaired patients (PERI)
Bayer Identifier:
13701
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southmead Hospital Bristol, United Kingdom, BS10 5NB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Ann Arbor, United States, 48109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins University Baltimore, United States, 21287 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Methodist Le Bonheur Healthcare Memphis, United States, 38104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Weill Cornell Medical College New York, United States, 10021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS INT Fondazione Pascale Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione del Piemonte per l'Oncologia Candiolo, Italy, 10060 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ISMETT Ist Mediterraneo Trapianti e Terapie ad alta special Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Europeo Oncologia - IEO Milano, Italy, 20141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Westmead Hospital Westmead NSW, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pusan National University Busan, South Korea, 602-739 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kangnam St.Marry’s Hospital Seoul, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SRH Wald-Klinikum Gera gGmbH Gera, Germany, 07548 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Otto-von-Guericke-Universität Magdeburg Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert-Bosch-Krankenhaus Stuttgart, Germany, 70376 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60596 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Precise Clinical Research Solutions/ Midwest Radiology Topeka, United States, 66604 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida College of Medicine Jacksonville, United States, 32209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maimonides Medical Center Brooklyn, United States, 11219 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Southern California-University Hospital Los Angeles, United States, 90033 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas Health Science Center San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Straub Clinic & Hospital Honolulu, United States, 96813 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL NA/2 Pozzuoli - Campania Pozzuoli, Italy, 80078 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Clinico Humanitas Rozzano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Cecilio Granada, Spain, 18012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Geelong Hospital Geelong, Australia, 3220 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Brisbane & Women's Hospital Herston, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Alexandra Hospital Woollongabba, Australia, 4102 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Songkla University Songkhla , Thailand, 90110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ramathibodhi Hospital Bangkok, Thailand | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of participants with moderate to severe renal impairment, who develop NSF (Nephrogenic systemic fibrosis), based on diagnostically specific clinical and histopathological informationTimeframe: Up to 24 months following the administration of Primovist/Eovist
Secondary Outcome
- 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 scoreTimeframe: 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)Timeframe: Immediately after Primovist/Eovist-enhanced MRI
- Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion detectionTimeframe: Immediately after Primovist/Eovist-enhanced MRI
- Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion delineationTimeframe: Immediately after Primovist/Eovist-enhanced MRI
- Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion characterizationTimeframe: Immediately after Primovist/Eovist-enhanced MRI
Additional Information
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