Nephrogenic Systemic FibrosisNCT01135316
Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
An observational study of Nephrogenic Systemic Fibrosis, run by Lantheus Medical Imaging at 2 sites in United States.
Trial summary
Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrogenic Systemic Fibrosis
- What is being tested?
- Ablavar
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with moderate to severe kidney disease
Who may be able to join
- Kidney Disease with GFR < 60 mL/min./1.73 m^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.
Who cannot join
- History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment.
- Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations.
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives.
- Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Weill Cornell Medical College
New York, New York, 10022
About this study
Official title: A Phase 4, Open-Label, Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Kidney Disease Undergoing Magnetic Resonance Imaging (MRI) With Ablavar (Gadofosveset Trisodium) in Routine Clinical Practice
Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.
Read the detailed description
Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States. All patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management. Prior to undergoing an Ablavar MRI, patients will have a baseline serum creatinine test within 24 hours prior to Ablavar administration, will sign an Informed Consent (IC) form, will undergo a limited exam for skin abnormalities, and will undergo a brief medical history assessment on the day of and prior to Ablavar administration. A standardized NSF questionnaire will be administered to the patient at 48 (+ or -12) hours, 1 month (+ or - 1 week), 3 months (+ or - 2 weeks), 6 (+ or - 1) months, and 18 (+ or - 1) months post-dose. At 12 (+ or - 1) months, and at 24 (+ or - 1) months. Patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.
- Conditions
- Nephrogenic Systemic Fibrosis
- Being tested
- Ablavar
- Keywords
- NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),
- Medical subject headings
- Nephrogenic Fibrosing Dermopathy, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblavarDrug
One dose of Ablavar will be administered for use during a contrast MRI examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nephrogenic Systemic Fibrosis
Measured: 24 months
Secondary outcomes (1)
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrogenic Systemic FibrosisStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon P Robinson, PhD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135316
- Sponsor's protocol ID
- LMI-Ablavar-401
- Status last verified
- May 2014
- First submitted
- 1 Jun 2010
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Kidney Disease Undergoing Magnetic Resonance Imaging (MRI) With Ablavar (Gadofosveset Trisodium) in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01135316
- Acronym / sponsor ID
- LMI-Ablavar-401
- Conditions
- Nephrogenic Systemic Fibrosis
- Keywords
- NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.
Detailed description
Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States. All patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management. Prior to undergoing an Ablavar MRI, patients will have a baseline serum creatinine test within 24 hours prior to Ablavar administration, will sign an Informed Consent (IC) form, will undergo a limited exam for skin abnormalities, and will undergo a brief medical history assessment on the day of and prior to Ablavar administration. A standardized NSF questionnaire will be administered to the patient at 48 (+ or -12) hours, 1 month (+ or - 1 week), 3 months (+ or - 2 weeks), 6 (+ or - 1) months, and 18 (+ or - 1) months post-dose. At 12 (+ or - 1) months, and at 24 (+ or - 1) months. Patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe kidney disease
Key inclusion criteria (1 listed)
- Kidney Disease with GFR < 60 mL/min./1.73 m^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.
Key exclusion criteria (4 listed)
- History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment.
- Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations.
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives.
- Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.
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 |
|---|---|---|
| AblavarOne dose of Ablavar will be administered for use during a contrast MRI examination | Drug | – |
Primary outcome
Incidence of Nephrogenic Systemic Fibrosis
Time frame: 24 months
1 secondary outcome
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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.
Simon P Robinson, PhD study director
Lantheus Medical Imaging
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrogenic Systemic Fibrosis, run by Lantheus Medical Imaging at 2 sites in United States.
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 4 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Nephrogenic Systemic Fibrosis (time frame: 24 months). 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 7 May 2014.