Safety of Gadovist in Renally Impaired Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Fibrosis Renal Impairment	Drug: Gadobutrol (Gadovist, BAY86-4875)	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Flu MRI Scans

Drug Information available for: Gadobutrol

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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: Within 2 years, after administration of Gadovist ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Confidence of the investigator to make a diagnosis based on the Gadovist enhanced magnetic resonance imaging (MRI) and to qualitatively assess the image quality [ Time Frame: Immediately after Gadovist-enhanced MRI ] [ Designated as safety issue: No ]
Adverse events collection [ Time Frame: Immediately after Gadovist-enhanced MRI ] [ Designated as safety issue: Yes ]
Characterize patients with moderate and severe renal impairment regarding specific cytokine expression in serum to evaluate potential co-factors under discussion in the pathogenesis of NSF [ Time Frame: At baseline (prior to Gadovist-enhanced MRI) ] [ Designated as safety issue: No ]

Enrollment:	928
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Gadobutrol (Gadovist, BAY86-4875) Gadovist in approved indications at approved dosages

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828737

Show 70 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00828737 History of Changes
Other Study ID Numbers:	13273, 2008-004496-22
Study First Received:	December 18, 2008
Last Updated:	April 15, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Switzerland: Swissmedic Korea: Korean Food and Drug Administration Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines Thailand: Food and Drug Administration

Additional relevant MeSH terms:

Fibrosis
Renal Insufficiency
Nephrogenic Fibrosing Dermopathy
Pathologic Processes

Kidney Diseases
Urologic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Safety of Gadovist in Renally Impaired Patients (GRIP)