Clinical Trial: Primovist / Eovist 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 Primovist/Eovist in Patients With Moderat

Brief Summary:

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist 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 Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist 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: Adverse events data will be reported in Adverse Events section.
Sponsor: Bayer

Current Primary Outcome: Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information [ Time Frame: Up to 24 months following the administration of Primovist/Eovist ]

A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.


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 Primovist/Eovist ]

Current Secondary Outcome:

  • Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score [ Time Frame: Up to 24 months following the administration of Primovist/Eovist ]
    Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
  • Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]
    The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
  • Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]
    The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
  • Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]
    The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
  • Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]
    The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.


Original Secondary Outcome:

  • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist® enhanced MRI and to qualitatively assess the image quality [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]
  • Adverse events [ Time Frame: Immediately after Primovist/Eovist-enhanced MRI ]


Information By: Bayer

Dates:
Date Received: May 26, 2009
Date Started: May 2009
Date Completion:
Last Updated: July 1, 2015
Last Verified: July 2015