Nephrogenic Fibrosing DermopathyPhase 4NFDNCT01078987
Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)
A Phase 4 study testing Plasmapheresis in people with Nephrogenic Fibrosing Dermopathy and Nephrogenic Systemic Fibrosis, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrogenic Fibrosing Dermopathy, Nephrogenic Systemic Fibrosis
- What is being tested?
- Plasmapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Mar 2012
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with NFD/NSF following a kidney transplant
- diagnosed with NFD/NSF following a liver transplant
- NFD/NSF and who have not had a kidney or liver transplant
- diagnosed with NFD/NSF and who have not had a kidney or liver transplant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).
- Being tested
- Plasmapheresis
- Keywords
- Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF)
- 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.
PlasmapheresisProcedure or surgery
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | One to three 5-day course of plasma exchange (plasmapheresis) Receives: Procedure: Plasmapheresis |
| Group 2 | Active comparator | One to three 5-day course of plasma exchange (plasmapheresis) Receives: Procedure: Plasmapheresis |
| Group 3 | No intervention | No intervention taken |
| Group 4 | Active comparator | One to three 5-day course of plasma exchange (plasmapheresis) Receives: Procedure: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
Measured: Assessed two weeks after each monthly course of plasmapheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startFeb 2002
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrogenic Fibrosing DermopathyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Baron, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078987
- Sponsor's protocol ID
- 51018
- Acronym
- NFD
- Status last verified
- Nov 2014
- First submitted
- 5 Feb 2010
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
- ClinicalTrials.gov ID
- NCT01078987
- Acronym / sponsor ID
- NFD / 51018
- Keywords
- Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Mar 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.
The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: PlasmapheresisOne to three 5-day course of plasma exchange (plasmapheresis) |
| Group 2 | Active comparator | Procedure: PlasmapheresisOne to three 5-day course of plasma exchange (plasmapheresis) |
| Group 3 | No intervention | –No intervention taken |
| Group 4 | Active comparator | Procedure: PlasmapheresisOne to three 5-day course of plasma exchange (plasmapheresis) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with NFD/NSF following a kidney transplant
- diagnosed with NFD/NSF following a liver transplant
- NFD/NSF and who have not had a kidney or liver transplant
- diagnosed with NFD/NSF and who have not had a kidney or liver transplant
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlasmapheresisA course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses | Procedure or surgery | Group 1, Group 2, Group 4 |
Primary outcome
Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
Time frame: Assessed two weeks after each monthly course of plasmapheresis
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
Pedro Baron, MD principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasmapheresis in people with Nephrogenic Fibrosing Dermopathy and Nephrogenic Systemic Fibrosis, run by Loma Linda University at 1 site 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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin (time frame: Assessed two weeks after each monthly course of plasmapheresis). 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 21 Nov 2014.