Safety of Gadovist in Renally Impaired Patients
GRIP
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
2 other identifiers
interventional
927
9 countries
64
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Longer than P75 for phase_4
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
January 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 18, 2016
February 1, 2016
6.1 years
December 18, 2008
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information
From the time of MRI until the end of follow-up period (24 months)
Secondary Outcomes (7)
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 Information
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 on
Immediately after Gadovist-enhanced MRI
Number of Participants With Image Quality Sufficient for Diagnosis
Immediately after Gadovist-enhanced MRI
Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
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 Impairment
Within 48 hours prior to the Gadovist administration
- +2 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (70)
Unknown Facility
Adelaide, South Australia, 5000, Australia
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Clayton, Victoria, 3168, Australia
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Geelong, Victoria, 3220, Australia
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Westmead NSW, 2145, Australia
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Innsbruck, Tyrol, 6020, Austria
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Ehenbichl, 6600, Austria
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Graz, 8036, Austria
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Leoben, 8700, Austria
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Vienna, 1030, Austria
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Vienna, 1090, Austria
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Calgary, Alberta, T2N 2T9, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Fleurimont, Quebec, J1H 5N4, Canada
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Le Kremlin-Bicêtre, 94275, France
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Lille, 59037, France
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Marseille, 13385, France
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Paris, 75908, France
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Reims, 51092, France
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Mannheim, Baden-Wurttemberg, 68167, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Coburg, Bavaria, 96450, Germany
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Erlangen, Bavaria, 91054, Germany
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München, Bavaria, 81377, Germany
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Regensburg, Bavaria, 93053, Germany
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Neuruppin, Brandenburg, 16816, Germany
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Hamburg, Hamburg, 21031, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Hannoversch Münden, Lower Saxony, 34346, Germany
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Osnabrück, Lower Saxony, 49076, Germany
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Dortmund, North Rhine-Westphalia, 44263, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Lüdenscheid, North Rhine-Westphalia, 58515, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04289, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Berlin, State of Berlin, 12200, Germany
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Berlin, State of Berlin, 12351, Germany
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Gera, Thuringia, 07548, Germany
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Rozzano, Milano, 20089, Italy
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Ancona, 60126, Italy
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Brescia, 25123, Italy
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Florence, 50139, Italy
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Genova, 16132, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Pisa, 56124, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Treviso, 31100, Italy
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Verona, 37134, Italy
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Seongnam-si, Gyeonggido, 463-707, South Korea
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Seoul, Seoul Teugbyeolsi, 110-744, South Korea
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Busan, 602-739, South Korea
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Jeonju-Si, Jeonrabuk-Do, 561-712, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
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Barcelona, Barcelona, 08036, Spain
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Sabadell, Barcelona, 08208, Spain
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Granada, Granada, 18012, Spain
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Basel, Canton of Basel-City, 4031, Switzerland
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Lugano, Canton Ticino, 6900, Switzerland
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Bangkok, 10700, Thailand
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Bangkok, Thailand
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Songkhla, 90110, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
January 26, 2009
Study Start
December 1, 2008
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 18, 2016
Record last verified: 2016-02