check_circleStudy Completed
Fibrosis, Renal Impairment
Bayer Identifier:
13273
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety of Gadovist in Renally Impaired Patients
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.
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.
Key Participants Requirements
Sex
BothAge
2 - N/ATrial summary
Enrollment Goal
927Trial Dates
December 2008 - January 2015Phase
Phase 4Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum Osnabrück GmbH | Osnabrück, 49076, Germany |
Completed | Universitätsklinikum Erlangen | Erlangen, 91054, Germany |
Completed | Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH | Lüdenscheid, 58515, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Terminated | Nephrologisches Zentrum Niedersachsen | Hannoversch Münden, 34346, Germany |
Terminated | C.H.U. Timone | Marseille, 13385, France |
Terminated | Centre Hospitalier Universitaire - Le Kremlin Bicêtre | LE KREMLIN-BICETRE, 94275, France |
Terminated | CHRU Hôpital Cardiologique | Lille Cedex, 59037, France |
Completed | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Completed | A.O.U. Integrata Verona | Verona, 37134, Italy |
Completed | A.O. Spedali Civili | Brescia, 25123, Italy |
Completed | Università La Sapienza | Roma, 00161, Italy |
Terminated | A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi | Ancona, 60126, Italy |
Completed | IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro | Genova, 16132, Italy |
Completed | Klinikum Mannheim gGmbH | Mannheim, 68167, Germany |
Completed | Klinikum der Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Klinikum Coburg gGmbH | Coburg, 96450, Germany |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04289, Germany |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60596, Germany |
Terminated | Hôpital Europeen Georges Pompidou | Paris, 75908, France |
Terminated | Hopital Maison Blanche | REIMS, 51092, France |
Completed | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Completed | AULSS 09 Treviso - Veneto | Treviso, 31100, Italy |
Completed | A.O.U. Pisana | Pisa, 56124, Italy |
Terminated | A.O. Città della Salute e della Scienza di Torino | Torino, 10126, Italy |
Completed | A.O.U. Meyer | Firenze, 50139, Italy |
Completed | Foothills Medical Centre | Calgary, T2N 2T9, Canada |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Corporació Sanitària Parc Taulí | Sabadell, 08208, Spain |
Completed | St. Joseph's Healthcare - Hamilton | Hamilton, L8N 4A6, Canada |
Completed | Toronto General Hospital-University Health Network | Toronto, M5G 2N2, Canada |
Terminated | Monash Medical Centre | Clayton, 3168, Australia |
Completed | Geelong Hospital | Geelong, 3220, Australia |
Terminated | Westmead Hospital | Westmead NSW, 2145, Australia |
Completed | Universitätsklinikum Innsbruck | Innsbruck, 6020, Austria |
Completed | A. ö. Landeskrankenhaus Leoben | Leoben, 8700, Austria |
Completed | Krankenanstalt der Stadt Wien - Rudolfstiftung | Wien, 1030, Austria |
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Bezirkskrankenhaus Reutte | Ehenbichl, 6600, Austria |
Completed | Chonbuk National University Hospital | Jeonju-Si, Jeonrabuk-Do, 561-712, Korea, Republic Of |
Completed | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, 137-701, Korea, Republic Of |
Completed | Cente Hospitalier Universitaire de Sherbrooke-Fleurimont | Fleurimont, J1H 5N4, Canada |
Completed | Sunnybrook Health Sciences Centre | Toronto, M4N 3M5, Canada |
Terminated | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Severance Hospital, Yonsei University College of Medicine | Seoul, 120-752, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Terminated | Ospedale regionale di Lugano | Lugano, 6900, Switzerland |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Completed | Westmead Hospital | Westmead NSW, 2145, Australia |
Completed | LMU Klinikum der Universität München - Großhadern | München, 81377, Germany |
Completed | Universitätsklinikum Regensburg | Regensburg, 93053, Germany |
Completed | Seoul Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Ruppiner Kliniken GmbH | Neuruppin, 16816, Germany |
Completed | Vivantes Klinikum Neukölln | Berlin, 12351, Germany |
Completed | Hanserad Radiologie Hamburg Praxisklinik Bergedorf | Hamburg, 21031, Germany |
Completed | Otto-von-Guericke-Universität Magdeburg | Magdeburg, 39120, Germany |
Completed | SRH Wald-Klinikum Gera gGmbH | Gera, 07548, Germany |
Completed | Hospital Clínico Universitario San Cecilio | Granada, 18012, Spain |
Completed | Prince of Songkla University | Songkhla, 90110, Thailand |
Terminated | Siriraj Hospital, Mahidol | Bangkok, 10700, Thailand |
Completed | Ramathibodhi Hospital | Bangkok, Thailand |
Terminated | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | St. Josefs-Hospital | Dortmund, 44263, Germany |
Terminated | IRCCS INT Fondazione Pascale | Napoli, 80131, Italy |
Terminated | IRCCS Istituto Europeo Oncologia - IEO | Milano, 20141, Italy |
Completed | Pusan National University Hospital | Busan, 602-739, Korea, Republic Of |
Completed | Seoul National Univ. Bundang Hospital | SeongNam-si, 463-707, Korea, Republic Of |
Completed | IRCCS Istituto Clinico Humanitas | Rozzano, 20089, Italy |
Primary Outcome
- Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological informationdate_rangeTime Frame:From the time of MRI until the end of follow-up period (24 months)enhanced_encryptionyesSafety Issue:
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 Informationdate_rangeTime Frame:From the time of MRI until the end of follow-up period (24 months)enhanced_encryptionNoSafety Issue:
- Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based ondate_rangeTime Frame:Immediately after Gadovist-enhanced MRIenhanced_encryptionNoSafety Issue:
- Number of Participants With Image Quality Sufficient for Diagnosisdate_rangeTime Frame:Immediately after Gadovist-enhanced MRIenhanced_encryptionNoSafety Issue:
- Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairmentdate_rangeTime Frame:Within 48 hours prior to the Gadovist administrationenhanced_encryptionNoSafety Issue:
- Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairmentdate_rangeTime Frame:Within 48 hours prior to the Gadovist administrationenhanced_encryptionNoSafety Issue:
- Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairmentdate_rangeTime Frame:Within 48 hours prior to the Gadovist administrationenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:From the time of MRI until the end of follow-up period (24 months)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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