Safety of Gadovist in Renally Impaired Patients

Bayer927 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

927

Conditions

Fibrosis Renal Impairment

Interventions

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Locations (70)

Unnamed facility

Adelaide, South Australia, Australia

Unnamed facility

Clayton, Victoria, Australia

Unnamed facility

Geelong, Victoria, Australia

Unnamed facility

Westmead NSW, Australia

Unnamed facility

Innsbruck, Tyrol, Austria

Unnamed facility

Outcomes

Primary Outcomes

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 Outcomes

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)