Clinical Trial: Safety of Gadovist in Renally Impaired Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Sev

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.


Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: 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) ]

Original Primary Outcome: Number of patients with moderate to severe renal impairment, who develop NSF, based on diagnostically specific clinical and histopathological information [ Time Frame: Within 2 years, after administration of Gadovist ]

Current 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 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) ]


Original Secondary Outcome:

  • Confidence of the investigator to make a diagnosis based on the Gadovist enhanced MRI and to qualitatively assess the image quality [ Time Frame: Immediately after Gadovist-enhanced MRI ]
  • Adverse events [ Time Frame: Immediately after Gadovist-enhanced MRI ]
  • Characterize patients with moderate and severe renal impairment regarding specific cytokine expression in serum to evaluate potential co-factors under discussion in the pathogenesis of NSF [ Time Frame: At baseline (prior to Gadovist-enhanced MRI) ]


Information By: Bayer

Dates:
Date Received: December 18, 2008
Date Started: December 2008
Date Completion:
Last Updated: February 16, 2016
Last Verified: February 2016