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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00828737




Registration number
NCT00828737
Ethics application status
Date submitted
18/12/2008
Date registered
26/01/2009
Date last updated
18/02/2016

Titles & IDs
Public title
Safety of Gadovist in Renally Impaired Patients
Scientific 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
Secondary ID [1] 0 0
2008-004496-22
Secondary ID [2] 0 0
13273
Universal Trial Number (UTN)
Trial acronym
GRIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrosis 0 0
Renal Impairment 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gadobutrol (Gadovist, BAY86-4875)

Experimental: Arm 1 -


Treatment: Drugs: Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information
Timepoint [1] 0 0
From the time of MRI until the end of follow-up period (24 months)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From the time of MRI until the end of follow-up period (24 months)
Secondary outcome [2] 0 0
Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on
Timepoint [2] 0 0
Immediately after Gadovist-enhanced MRI
Secondary outcome [3] 0 0
Number of Participants With Image Quality Sufficient for Diagnosis
Timepoint [3] 0 0
Immediately after Gadovist-enhanced MRI
Secondary outcome [4] 0 0
Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
Timepoint [4] 0 0
Within 48 hours prior to the Gadovist administration
Secondary outcome [5] 0 0
Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment
Timepoint [5] 0 0
Within 48 hours prior to the Gadovist administration
Secondary outcome [6] 0 0
Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment
Timepoint [6] 0 0
Within 48 hours prior to the Gadovist administration
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
From the time of MRI until the end of follow-up period (24 months)

Eligibility
Key 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
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
927
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Westmead NSW
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
2145 - Westmead NSW
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Tirol
Country [2] 0 0
Austria
State/province [2] 0 0
Ehenbichl
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Leoben
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
France
State/province [9] 0 0
Le Kremlin-bicetre
Country [10] 0 0
France
State/province [10] 0 0
Lille Cedex
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Reims
Country [14] 0 0
Germany
State/province [14] 0 0
Baden-Württemberg
Country [15] 0 0
Germany
State/province [15] 0 0
Bayern
Country [16] 0 0
Germany
State/province [16] 0 0
Brandenburg
Country [17] 0 0
Germany
State/province [17] 0 0
Hessen
Country [18] 0 0
Germany
State/province [18] 0 0
Niedersachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Sachsen-Anhalt
Country [21] 0 0
Germany
State/province [21] 0 0
Sachsen
Country [22] 0 0
Germany
State/province [22] 0 0
Thüringen
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Italy
State/province [26] 0 0
Ancona
Country [27] 0 0
Italy
State/province [27] 0 0
Brescia
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Genova
Country [30] 0 0
Italy
State/province [30] 0 0
Napoli
Country [31] 0 0
Italy
State/province [31] 0 0
Pisa
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Italy
State/province [34] 0 0
Treviso
Country [35] 0 0
Italy
State/province [35] 0 0
Verona
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gyeonggido
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul Teugbyeolsi
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Jeonju-Si, Jeonrabuk-Do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Granada
Country [43] 0 0
Switzerland
State/province [43] 0 0
Basel-Stadt
Country [44] 0 0
Switzerland
State/province [44] 0 0
Ticino
Country [45] 0 0
Thailand
State/province [45] 0 0
Bangkok
Country [46] 0 0
Thailand
State/province [46] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00828737
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00828737