Clinical trial NCT00828737: Safety of Gadovist in Renally Impaired Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibrosis
Renal Impairment
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 927
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information
timeFrame: From the time of MRI until the end of follow-up period (24 months)
Secondary outcomes:
measure: 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
timeFrame: From the time of MRI until the end of follow-up period (24 months)
measure: Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on
timeFrame: Immediately after Gadovist-enhanced MRI
measure: Number of Participants With Image Quality Sufficient for Diagnosis
timeFrame: Immediately after Gadovist-enhanced MRI
measure: Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
timeFrame: Within 48 hours prior to the Gadovist administration
measure: Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment
timeFrame: Within 48 hours prior to the Gadovist administration
measure: Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment
timeFrame: Within 48 hours prior to the Gadovist administration
measure: 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)
timeFrame: From the time of MRI until the end of follow-up period (24 months)
Other outcomes:
Locations:
city: Adelaide
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Westmead NSW
country: Australia
city: Innsbruck
country: Austria
state: Tirol
city: Ehenbichl
country: Austria
city: Graz
country: Austria
city: Leoben
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Fleurimont
country: Canada
state: Quebec
city: Le Kremlin-bicetre
country: France
city: Lille Cedex
country: France
city: Marseille
country: France
city: Paris
country: France
city: Reims
country: France
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Coburg
country: Germany
state: Bayern
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Neuruppin
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Hannoversch Münden
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Lüdenscheid
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Rozzano
country: Italy
state: Milano
city: Ancona
country: Italy
city: Brescia
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Treviso
country: Italy
city: Verona
country: Italy
city: SeongNam-si
country: Korea, Republic of
state: Gyeonggido
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
city: Jeonju-Si, Jeonrabuk-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Sabadell
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Basel
country: Switzerland
state: Basel-Stadt
city: Lugano
country: Switzerland
state: Ticino
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: