Trial Condition(s):
Fibrosis, Renal Impairment
Safety of Gadovist in Renally Impaired Patients (GRIP)
Bayer Identifier:
13273
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, Gadovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Gadovist 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 Gadovist. Patients who are enrolled in this study will receive a Gadovist 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
- Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR < 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI
Exclusion Criteria
- GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist - History of NSF (Nephrogenic Fibrosing Dermopathy) - Age outside the indicated age range mentioned in national labelling.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH Lüdenscheid, Germany, 58515 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nephrologisches Zentrum Niedersachsen Hannoversch Münden, Germany, 34346 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations C.H.U. Timone Marseille, France, 13385 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Le Kremlin Bicêtre LE KREMLIN-BICETRE, France, 94275 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHRU Hôpital Cardiologique Lille Cedex, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Integrata Verona Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Università La Sapienza Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Coburg gGmbH Coburg, Germany, 96450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04289 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Europeen Georges Pompidou Paris, France, 75908 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Maison Blanche REIMS, France, 51092 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AULSS 09 Treviso - Veneto Treviso, Italy, 31100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Pisana Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Città della Salute e della Scienza di Torino Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Meyer Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Foothills Medical Centre Calgary, Canada, T2N 2T9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 4A6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toronto General Hospital-University Health Network Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Monash Medical Centre Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Geelong Hospital Geelong, Australia, 3220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead NSW, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A. ö. Landeskrankenhaus Leoben Leoben, Austria, 8700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenanstalt der Stadt Wien - Rudolfstiftung Wien, Austria, 1030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bezirkskrankenhaus Reutte Ehenbichl, Austria, 6600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chonbuk National University Hospital Jeonju-Si, Jeonrabuk-Do, South Korea, 561-712 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Catholic University of Korea Seoul St. Mary's Hospital Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cente Hospitalier Universitaire de Sherbrooke-Fleurimont Fleurimont, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead NSW, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ruppiner Kliniken GmbH Neuruppin, Germany, 16816 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vivantes Klinikum Neukölln Berlin, Germany, 12351 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanserad Radiologie Hamburg Praxisklinik Bergedorf Hamburg, Germany, 21031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Otto-von-Guericke-Universität Magdeburg Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SRH Wald-Klinikum Gera gGmbH Gera, Germany, 07548 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario San Cecilio Granada, Spain, 18012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Songkla University Songkhla , Thailand, 90110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ramathibodhi Hospital Bangkok, Thailand | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Josefs-Hospital Dortmund, Germany, 44263 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS INT Fondazione Pascale Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituto Europeo Oncologia - IEO Milano, Italy, 20141 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pusan National University Hospital Busan, South Korea, 602-739 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National Univ. Bundang Hospital SeongNam-si, South Korea, 463-707 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituto Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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 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:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological informationTimeframe: From the time of MRI until the end of follow-up period (24 months)
Secondary Outcome
- Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy was Obtained who Develop Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical InformationTimeframe: From the time of MRI until the end of follow-up period (24 months)
- Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based onTimeframe: Immediately after Gadovist-enhanced MRI
- Number of Participants With Image Quality Sufficient for DiagnosisTimeframe: Immediately after Gadovist-enhanced MRI
- Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal ImpairmentTimeframe: Within 48 hours prior to the Gadovist administration
- Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal ImpairmentTimeframe: Within 48 hours prior to the Gadovist administration
- Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal ImpairmentTimeframe: Within 48 hours prior to the Gadovist administration
- Number of Participants With Treatmentemergent Adverse Events (TEAEs), Treatmentemergent Serious Adverse Event (TESAE), Drugrelated Treatmentemergent Adverse Events (TEAEs) and Drugrelated Treatmentemergent Serious Adverse Events (TESAEs)Timeframe: From the time of MRI until the end of follow-up period (24 months)
Additional Information
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