Atypical Hemolytic Uremic SyndromeNCT02626663
The Role of Microparticles as a Biomarker
An observational study of Atypical Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura, run by University of Rochester at 1 site in United States.
Trial summary
The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atypical Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura, Microparticles
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2022
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.
Who may be able to join
- Patients with MAHA, TTP, and/or aHUS
Who cannot join
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York
About this study
Official title: The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)
The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.
- Conditions
- Atypical Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura, Microparticles, Microangiopathic Hemolytic Anemia
- Medical subject headings
- Atypical Hemolytic Uremic Syndrome, Purpura, Thrombotic Thrombocytopenic, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aHUS | atypical Hemolytic Uremic Syndrome | |
| TTP | Thrombotic thrombocytopenic purpura | |
| MAHA | other microangiopathic hemolytic anemias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microparticle/Nanoparticle number (an absolute number)
Measured: an average of 3 months
Microparticle/Nanoparticle size (in nanometers or micrometers)
Measured: an average of 3 months
Microparticle/Nanoparticle identity (identity of cell type from which they are derived)
Measured: an average of 3 months
Secondary outcomes (2)
Morbidities
Measured: 3 months
Mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJul 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: PI left the University, sponsor pulled funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Hemolytic Uremic SyndromeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majed Refaai, University of Rochester
- Investigators
- Amy Schmidt, MD PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626663
- Sponsor's protocol ID
- RSRB00059370
- Status last verified
- Feb 2019
- First submitted
- 20 Oct 2015
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)
- ClinicalTrials.gov ID
- NCT02626663
- Acronym / sponsor ID
- RSRB00059370
- Conditions
- Atypical Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura, Microparticles, Microangiopathic Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the University, sponsor pulled funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Dec 2015 (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 investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aHUS | – | –atypical Hemolytic Uremic Syndrome |
| TTP | – | –Thrombotic thrombocytopenic purpura |
| MAHA | – | –other microangiopathic hemolytic anemias |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.
Key inclusion criteria (1 listed)
- Patients with MAHA, TTP, and/or aHUS
Key exclusion criteria (1 listed)
- Prisoners
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
Microparticle/Nanoparticle number (an absolute number)
Time frame: an average of 3 months
Microparticle/Nanoparticle size (in nanometers or micrometers)
Time frame: an average of 3 months
Microparticle/Nanoparticle identity (identity of cell type from which they are derived)
Time frame: an average of 3 months
2 secondary outcomes
Morbidities
Time frame: 3 months
Mortality
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
Amy Schmidt, MD PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura, run by University of Rochester 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 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: withdrawn, as of the sponsor's last update on 19 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Microparticle/Nanoparticle number (an absolute number) (time frame: an average of 3 months). The study lists 3 primary outcomes in all. 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 19 Feb 2019.