Safety of Gadovist in Renally Impaired Patients

Phase 4

Completed

• Conditions: Fibrosis; Renal Impairment
• Interventions: Drug: Gadobutrol (Gadovist, BAY86-4875)

• Registration Number: NCT00828737
• Lead Sponsor: Bayer

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 927

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Gadobutrol (Gadovist, BAY86-4875)	-

Primary Outcome Measures

Name	Time	Method
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information	From the time of MRI until the end of follow-up period (24 months)

Secondary Outcome Measures

Name	Time	Method
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	From the time of MRI until the end of follow-up period (24 months)
Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment	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	Within 48 hours prior to the Gadovist administration
Number of Participants With Image Quality Sufficient for Diagnosis	Immediately after Gadovist-enhanced MRI
Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment	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)	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	Immediately after Gadovist-enhanced MRI