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Safety of Gadovist in Renally Impaired Patients (GRIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828737
First Posted: January 26, 2009
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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) ]

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) ]
  • Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on [ Time Frame: Immediately after Gadovist-enhanced MRI ]
  • Number of Participants With Image Quality Sufficient for Diagnosis [ Time Frame: Immediately after Gadovist-enhanced MRI ]
  • Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment [ Time Frame: 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 [ Time Frame: 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 Impairment [ Time Frame: 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) [ Time Frame: From the time of MRI until the end of follow-up period (24 months) ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828737


  Show 70 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00828737     History of Changes
Other Study ID Numbers: 13273
2008-004496-22 ( EudraCT Number )
First Submitted: December 18, 2008
First Posted: January 26, 2009
Last Update Posted: February 18, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Fibrosis
Renal Insufficiency
Pathologic Processes
Kidney Diseases
Urologic Diseases