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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00908596