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Clinical trials for Nephrogenic systemic fibrosis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    10 result(s) found for: Nephrogenic systemic fibrosis. Displaying page 1 of 1.
    EudraCT Number: 2009-013295-48 Sponsor Protocol Number: 22505 Start Date*: 2009-09-04
    Sponsor Name:Århus University Hospital, Department of Dermatology
    Full Title: Treatment of patients with Nephrogenic Systemic Fibrosis(NSF) with Imatinib Mesylate(Glivec). An open label clinical trial among patients with moderate to severe NSF.
    Medical condition: Nephrogenic Systemic Fibrosis (NSF) is a fibrosing disease strongly associated with Gadolinium Based Contrast Agents(GBCA). Hard dermal plaques appear on legs, arms and abdomen. The lesions involve...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10067467 Nephrogenic systemic fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2009-011236-35 Sponsor Protocol Number: GE-041-075 Start Date*: 2009-10-13
    Sponsor Name:GE Healthcare Limited and its Affiliates
    Full Title: A post-marketing safety study in patients with moderate renal insufficiency who receive Omniscan (Gadodiamide Injection) for contrast enhanced magnetic resonance imaging (MRI) Estudio de seguridad...
    Medical condition: Patients with moderate renal insufficiency (estimated eGFR > 30 and <60 mL/min/1.73m2). Pacientes con insuficiencia renal moderada (tasa de filtración glomerular [TFG] >estimada 30 y <60 ml/min/1,...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064499 Nephrogenic fibrosing dermopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-022570-13 Sponsor Protocol Number: GAD-1140-WIL-0020-I Start Date*: Information not available in EudraCT
    Sponsor Name:Medizinsiche Fakultät der Technischen Universität München
    Full Title: Gadovit-Studie Intraindividueller Vergleich der diagnostischen Wertigkeit von delayed-enhancement imaging mit Gadobutrol (Gadovist®) versus Gadobenat Dimeglumin (Multihance®) mittels einer MRT Bi...
    Medical condition: Rupture of a thrombotic plaque within a coronary artery leads to a complete or incomplete occlusion of the vessel with subsequent ischemia in the affected myocardium. If not revascularised within ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001439-30 Sponsor Protocol Number: ALS-Gd64/001 Start Date*: 2013-03-22
    Sponsor Name:Navitas Life Sciences GmbH
    Full Title: Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history.
    Medical condition: Retention of gadolinium/traces of metals/minerals to be determined in bone/skin specimens and evaluation of signs of nephrogenic systemic fibrosis in skin.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000941-11 Sponsor Protocol Number: GMRA-102,Am.No.1 Start Date*: 2013-03-27
    Sponsor Name:Bracco Imaging S.p.A.
    Full Title: A PROSPECTIVE MULTICENTER COHORT STUDY EVALUATING THE LONG TERM RETENTION OF GADOLINIUM IN HUMAN BONE AND SKIN AFTER THE RETROSPECTIVE ADMINISTRATION OF MULTIHANCE® OR PROHANCE® IN COMPARISON WITH...
    Medical condition: Nephrogenic Systemic Fibrosis (NSF)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-004496-22 Sponsor Protocol Number: 13273 Start Date*: 2008-11-13
    Sponsor Name:Bayer Health Care AG
    Full Title: Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Gadovist® in patients with moderate to...
    Medical condition: Patients with moderate to severe renal impairment.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10038469 Renal impairment NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003589-16 Sponsor Protocol Number: PH-106 Start Date*: 2010-02-25
    Sponsor Name:BRACCO IMAGING
    Full Title: A PROSPECTIVE COHORT STUDY EVALUATING THE INCIDENCE OF NEPHROGENIC SYSTEMIC FIBROSIS IN PATIENTS WITH STAGES 3 TO 5 CHRONIC KIDNEY DISEASE UNDERGOING MRI WITH THE INJECTION OF PROHANCE
    Medical condition: Safety of Contrast enhanced MRI diagnoses in patients suffering from some chronic kidney disease stage 3 (cohort 1) or stage 4 to 5 (cohort 2)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029820 LLT
    9.1 10038359 SOC
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005867-33 Sponsor Protocol Number: 13701 Start Date*: 2009-03-10
    Sponsor Name:Bayer HealthCare AG
    Full 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 mode...
    Medical condition: Patients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004857 10038469 Renal impairment NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003825-31 Sponsor Protocol Number: GDX-44-015 Start Date*: 2022-02-28
    Sponsor Name:Guerbet
    Full Title: Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI P/0145/2019
    Medical condition: Known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging) that need to be investigated by contrast-enhanced MRI of any body regio...
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004848 10029815 Nuclear magnetic resonance imaging LLT
    22.1 100000004848 10058644 Nuclear magnetic resonance imaging whole body LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001516-30 Sponsor Protocol Number: GDX-44-007 Start Date*: Information not available in EudraCT
    Sponsor Name:GUERBET
    Full Title: Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of ageundergoing contrast-enhanced MRI.
    Medical condition: Pediatric subjects from 2 to 17 years old scheduled to undergo routine gadolinium contrast enhanced Magnetic Resonance Imaging of Central Nervous System
    Disease: Version SOC Term Classification Code Term Level
    21.1 10022891 - Investigations 10029817 Nuclear magnetic resonance imaging brain PT
    21.1 10022891 - Investigations 10072232 Nuclear magnetic resonance imaging spinal PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Ongoing) PL (Completed) BG (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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