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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00908596




Registration number
NCT00908596
Ethics application status
Date submitted
26/05/2009
Date registered
27/05/2009
Date last updated
23/07/2015

Titles & IDs
Public title
Primovist / Eovist 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 Primovist/Eovist 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
2008-005867-33
Secondary ID [2] 0 0
13701
Universal Trial Number (UTN)
Trial acronym
PERI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast Media 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gadoxetic acid disodium (Primovist, BAY86-4873)

Experimental: Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) - Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.


Treatment: Drugs: Gadoxetic acid disodium (Primovist, BAY86-4873)
Primovist/Eovist 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 Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
Timepoint [1] 0 0
Up to 24 months following the administration of Primovist/Eovist
Secondary outcome [1] 0 0
Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
Timepoint [1] 0 0
Up to 24 months following the administration of Primovist/Eovist
Secondary outcome [2] 0 0
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Timepoint [2] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [3] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Timepoint [3] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [4] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Timepoint [4] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [5] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Timepoint [5] 0 0
Immediately after Primovist/Eovist-enhanced MRI

Eligibility
Key inclusion criteria
* Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
* Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
* History of existing NSF

Study design
Purpose of the study
Diagnosis
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
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Woollongabba
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Geelong
Recruitment hospital [5] 0 0
- Westmead NSW
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4102 - Woollongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
2145 - Westmead NSW
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Germany
State/province [13] 0 0
Baden-Württemberg
Country [14] 0 0
Germany
State/province [14] 0 0
Bayern
Country [15] 0 0
Germany
State/province [15] 0 0
Hessen
Country [16] 0 0
Germany
State/province [16] 0 0
Niedersachsen
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalen
Country [18] 0 0
Germany
State/province [18] 0 0
Sachsen-Anhalt
Country [19] 0 0
Germany
State/province [19] 0 0
Sachsen
Country [20] 0 0
Germany
State/province [20] 0 0
Thüringen
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Italy
State/province [24] 0 0
Torino
Country [25] 0 0
Italy
State/province [25] 0 0
Brescia
Country [26] 0 0
Italy
State/province [26] 0 0
Palermo
Country [27] 0 0
Italy
State/province [27] 0 0
Pisa
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
South Korea
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Spain
State/province [30] 0 0
Granada
Country [31] 0 0
Thailand
State/province [31] 0 0
Bangkok
Country [32] 0 0
Thailand
State/province [32] 0 0
Songkhla
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Bristol

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, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist 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 Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist 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/NCT00908596
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/NCT00908596