Primovist / Eovist in Renally Impaired Patients (PERI)

• ClinicalTrials.gov Identifier: NCT00908596
• Recruitment Status: Completed
• First Posted: May 27, 2009
• Results First Posted: August 7, 2014
• Last Update Posted: July 23, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: May 26, 2009
• First Posted Date: May 27, 2009
• Results First Submitted Date: July 15, 2014
• Results First Posted Date: August 7, 2014
• Last Update Posted Date: July 23, 2015
• Study Start Date: May 2009
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 15, 2014)

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 Measures (submitted: May 26, 2009): 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 Measures (submitted: July 15, 2014)

• 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 Measures (submitted: May 26, 2009)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Primovist / Eovist in Renally Impaired Patients
• 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 Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.

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 Description: Adverse events data will be reported in Adverse Events section.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Contrast Media

Intervention

Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Primovist/Eovist in approved indications at approved dosages

Study Arms

Experimental: Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)

Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.

Intervention: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2014): 357
• Original Estimated Enrollment (submitted: May 26, 2009): 1000
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
• Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.

Exclusion Criteria:

• Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
• History of existing NSF

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Germany, Italy, Korea, Republic of, Spain, Thailand, United Kingdom, United States

Administrative Information

• NCT Number: NCT00908596
• Other Study ID Numbers: 13701; 2008-005867-33 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: July 2015