Safety of Gadovist in Renally Impaired Patients

Renal Impairment Clinical Trial

— GRIP  

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 Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828737
• Other study ID #: 13273
• Secondary ID: 2008-004496-22
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2008
• Last updated: February 16, 2016
• Start date: December 2008
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaSwitzerland: SwissmedicKorea: Korean Food and Drug AdministrationAustria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 927
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Nephrogenic Fibrosing Dermopathy
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Spain,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	No
Secondary	Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on		Immediately after Gadovist-enhanced MRI	No
Secondary	Number of Participants With Image Quality Sufficient for Diagnosis		Immediately after Gadovist-enhanced MRI	No
Secondary	Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment		Within 48 hours prior to the Gadovist administration	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes

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