Contrast MediaPhase 4PERINCT00908596
Primovist / Eovist in Renally Impaired Patients
A Phase 4 study testing Gadoxetic acid disodium (Primovist, BAY86-4873) in people with Contrast Media, run by Bayer at 47 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Media
- What is being tested?
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 47 sitesin 9 countries
- Study dates
- May 2009to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
47 sites in 9 countries.
47 sites in 9 countries
United States12 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Baltimore, Maryland, 21287
Study site
Brooklyn, New York, 11219
Study site
Durham, North Carolina, 27710
Study site
Honolulu, Hawaii, 96813
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32209
Study site
Los Angeles, California, 90033
Study site
Memphis, Tennessee, 38104
Study site
New York, New York, 10021
Study site
San Antonio, Texas, 78229
Study site
Topeka, Kansas, 66604
Germany12 sites
Study site
Berlin, State of Berlin, 12200
Study site
Dortmund, North Rhine-Westphalia, 44137
Study site
Dresden, Saxony, 01307
Study site
Erlangen, Bavaria, 91054
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Frankfurt am Main, Hesse, 60596
Study site
Gera, Thuringia, 07548
Study site
Hanover, Lower Saxony, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Magdeburg, Saxony-Anhalt, 39120
Study site
Marburg, Hesse, 35033
Study site
Stuttgart, Baden-Wurttemberg, 70376
Italy8 sites
Study site
Brescia, 25123
Study site
Candiolo, Torino, 10060
Study site
Milan, 20141
Study site
Naples, 80131
Study site
Palermo, 90127
Study site
Pisa, 56124
Study site
Pozzuoli, Napoli, 80078
Study site
Rozzano, Milano, 20089
Australia5 sites
Study site
Adelaide, South Australia, 5000
Study site
Geelong, Victoria, 3220
Study site
Herston, Queensland, 4029
Study site
Westmead NSW, 2145
Study site
Woollongabba, Queensland, 4102
South Korea3 sites
Study site
Busan, South Korea, 602-739
Study site
Seoul, South Korea
Study site
Seoul, 138-736
Thailand3 sites
Study site
Bangkok, 10700
Study site
Bangkok
Study site
Songkhla, 90110
About this study
Official 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.
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.
Read the detailed description
Adverse events data will be reported in Adverse Events section.
- Conditions
- Contrast Media
- Being tested
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- Keywords
- Nephrogenic Systemic Fibrosis (NSF), Primovist / Eovist
- Medical subject headings
- Nephrogenic Fibrosing Dermopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoxetic acid disodium (Primovist, BAY86-4873)Drug
Primovist/Eovist in approved indications at approved dosages
| Study group | Role | What they receive |
|---|---|---|
| Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) | Experimental | Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously. Receives: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months following the administration of Primovist/Eovist
Secondary outcomes (5)
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.
Measured: Up to 24 months following the administration of Primovist/Eovist
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.
Measured: Immediately after Primovist/Eovist-enhanced MRI
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.
Measured: Immediately after Primovist/Eovist-enhanced MRI
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.
Measured: Immediately after Primovist/Eovist-enhanced MRI
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.
Measured: Immediately after Primovist/Eovist-enhanced MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contrast MediaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908596
- Sponsor's protocol ID
- 13701
- Other IDs
- 2008-005867-33, 2008
- Acronym
- PERI
- Status last verified
- Jul 2015
- First submitted
- 26 May 2009
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00908596
- Acronym / sponsor ID
- PERI / 13701
- Conditions
- Contrast Media
- Keywords
- Nephrogenic Systemic Fibrosis (NSF), Primovist / Eovist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adverse events data will be reported in Adverse Events section.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) | Experimental | Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoxetic acid disodium (Primovist, BAY86-4873)Primovist/Eovist in approved indications at approved dosages | Drug | Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) |
Primary outcome
Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
Time frame: Up to 24 months following the administration of Primovist/Eovist
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.
5 secondary outcomes
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
Time frame: Up to 24 months following the administration of Primovist/Eovist
Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
Time frame: Immediately after Primovist/Eovist-enhanced MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
47 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadoxetic acid disodium (Primovist, BAY86-4873) in people with Contrast Media, run by Bayer at 47 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, Italy, Australia, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information (time frame: Up to 24 months following the administration of Primovist/Eovist). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.