Safety of Gadovist in Renally Impaired Patients - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00828737

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: Gadovist (Gadobutrol, BAY86-4875)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Prospective Non-randomized Cohort Study 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)

Resource links provided by NLM:

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 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 MRI and to qualitatively assess the image quality [ Time Frame: Immediately after Gadovist-enhanced MRI ] [ Designated as safety issue: No ]
Adverse events [ 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 ]

Estimated Enrollment:	1000
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 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-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) within 12 months prior to administration of Gadovist®
History of NSF (Nephrogenic Fibrosing Dermopathy)

Contacts and Locations

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

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 49 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:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	13273, EudraCT: 2008-004496-22
Study First Received:	December 18, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00828737 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Nephrogenic Systemic Fibrosis
NSF
Gadovist
Contrast Agents

Study placed in the following topic categories:

Fibrosis
Nephrogenic Systemic Fibrosis

Additional relevant MeSH terms:

Pathologic Processes
Fibrosis

ClinicalTrials.gov processed this record on September 10, 2009