Renal InsufficiencyNSsaFeNCT01467271
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
An observational study of Renal Insufficiency, run by Guerbet at 27 sites in 11 countries.
Trial summary
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem® Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency
- How many people
- 540 participants
- Where
- 27 sitesin 11 countries
- Study dates
- May 2011to Jun 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients with moderate to severe and end stage renal impairment or dialysis * Patients scheduled for a contrast-enhanced MRI with Dotarem
Who may be able to join
- Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
Who cannot join
- Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
Trial locations and contacts
27 sites in 11 countries.
27 sites in 11 countries
United States4 sites
Abington Memorial Hospital
Philadelphia, Pennsylvania
Covenant Health Care
Saginaw, Michigan
University of Texas Health Science Center
San Antonio, Texas
St. Louis University Medical Center
St Louis, Missouri
South Korea4 sites
Soonchunhyang Univ. Bucheon Hospital
Gyeonggi-do
Uijeongbu St. Mary's Hospital
Gyeonggi-do
Chung-Ang Univ. Medical Center
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Belgium3 sites
UZ Brussel
Brussels
AZ St Lucas
Ghent
H. Hartziekenhuis
Roeselare
Italy3 sites
Instituto Tumori Pascale
Naples
Ospedale Santa Maria
Pozzuoli
Universita campus Biomedico
Roma
Colombia2 sites
Hospital Universitario de San Ignacio
Bogotá
IATM (Instituto de alta tecnologia Medica de Antoquia)
Medellín
France2 sites
Hôpital Necker - Enfants malades
Paris
Hôpital Bois-Guillaume - CHU de Rouen
Rouen
Germany2 sites
Cardioangiologisches Centrum Bethanien
Frankfurt
Institute of Radiology and Neuroradiology
Frankfurt
Spain2 sites
Hospital Clínico San Carlos de Madrid
Madrid
CRC Hospital Universitari Sant Joan de Reus
Reus
Turkey (Türkiye)2 sites
Dişkapi Etlik Polikliniği
Ankara
Medeniyet University Goztepe Research and Training Hospital
Istanbul
United Kingdom2 sites
Royal Liverpool University Hospital
Liverpool
University Hospital of North Staffodshire
Stoke-on-Trent
About this study
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
Read the detailed description
All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms
- Conditions
- Renal Insufficiency
- Medical subject headings
- Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
Measured: All patients were followed up during 2 years after Dotarem administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2017
- Study completionJun 2017
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 Renal InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Desché, MD, Study director, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467271
- Sponsor's protocol ID
- DGD-55-003
- Acronym
- NSsaFe
- Status last verified
- Sep 2018
- First submitted
- 4 Nov 2011
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
- ClinicalTrials.gov ID
- NCT01467271
- Acronym / sponsor ID
- NSsaFe / DGD-55-003
- Conditions
- Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- May 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
Detailed description
All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients with moderate to severe and end stage renal impairment or dialysis * Patients scheduled for a contrast-enhanced MRI with Dotarem
Key inclusion criteria (1 listed)
- Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
Key exclusion criteria (1 listed)
- Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
Time frame: All patients were followed up during 2 years after Dotarem administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pierre Desché, MD study director
Guerbet
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, run by Guerbet at 27 sites in 11 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 1 inclusion and 1 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, South Korea, Belgium, Italy, Colombia and 6 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). 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 Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem (time frame: All patients were followed up during 2 years after Dotarem administration.). 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 4 Feb 2019.