Safety of Gadovist in Renally Impaired Patients (GRIP)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: December 18, 2008
Last updated: October 13, 2015
Last verified: October 2015

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.

Condition Intervention Phase
Renal Impairment
Drug: Gadobutrol (Gadovist, BAY86-4875)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information [ Time Frame: From the time of MRI until the end of follow-up period (24 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: From the time of MRI until the end of follow-up period (24 months) ] [ Designated as safety issue: No ]
  • Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on [ Time Frame: Immediately after Gadovist-enhanced MRI ] [ Designated as safety issue: No ]
  • Number of Participants With Image Quality Sufficient for Diagnosis [ Time Frame: Immediately after Gadovist-enhanced MRI ] [ Designated as safety issue: No ]
  • Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment [ Time Frame: Within 48 hours prior to the Gadovist administration ] [ Designated as safety issue: No ]
  • Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment [ Time Frame: Within 48 hours prior to the Gadovist administration ] [ Designated as safety issue: No ]
  • Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment [ Time Frame: Within 48 hours prior to the Gadovist administration ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: From the time of MRI until the end of follow-up period (24 months) ] [ Designated as safety issue: Yes ]

Enrollment: 927
Study Start Date: December 2008
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00828737

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00828737     History of Changes
Other Study ID Numbers: 13273, 2008-004496-22
Study First Received: December 18, 2008
Last Updated: October 13, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Switzerland: Swissmedic
Korea: Korean Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Nephrogenic Fibrosing Dermopathy
Renal Insufficiency
Kidney Diseases
Pathologic Processes
Skin Diseases
Urologic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions processed this record on November 27, 2015