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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00908596
Ethics application status
Date submitted
26/05/2009
Date registered
26/05/2009
Date last updated
1/07/2015

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
Contrast Media 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

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

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

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 - A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
Timepoint [1] 0 0
Up to 24 months following the administration of Primovist/Eovist
Primary outcome [2] 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 - A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
Timepoint [2] 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 - Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
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) - The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
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 - The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
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 - The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
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 - The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Timepoint [5] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [6] 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 - Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
Timepoint [6] 0 0
Up to 24 months following the administration of Primovist/Eovist
Secondary outcome [7] 0 0
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) - The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
Timepoint [7] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [8] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection - The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Timepoint [8] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [9] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation - The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Timepoint [9] 0 0
Immediately after Primovist/Eovist-enhanced MRI
Secondary outcome [10] 0 0
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization - The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
Timepoint [10] 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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications