StrokeEarly Phase 1DFONCT01365104
Modulation of Cerebral Blood Flow Using Iron Chelators
A Early Phase 1 study testing desferrioxamine in people with Stroke and Problem of Aging, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Problem of Aging
- What is being tested?
- desferrioxamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2014
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults between the ages of 18-80 years.
Who cannot join
- subjects taking vasoactive medications,
- hypertension,
- pregnant women, smokers,
- COPD,
- asthma,
- diabetes mellitus,
Show all 24Show fewer
- intracranial or carotid stenosis,
- hepatic disease,
- renal disease,
- bone marrow suppression,
- cardiac disease,
- heart failure,
- iron deficiency,
- history of cancer,
- history of head trauma,
- subarachnoid hemorrhage,
- central nervous system vasculitis,
- multiple sclerosis,
- migraines,
- seizures,
- sickle cell disease or trait,
- cardiac arrhythmia,
- unable to give informed consent, or
- poor transcranial Doppler insonation windows.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.
- Conditions
- Stroke, Problem of Aging
- Being tested
- desferrioxamine
- Keywords
- brain blood flow, stroke, cerebrovascular, aging, cerebrovascular hemodynamics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desferrioxamineDrug
Also called Desferal, desferoxamine
intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young | Experimental | Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other. Receives: Drug: desferrioxamine |
| healthy old | Experimental | Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other. Receives: Drug: desferrioxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define change from baseline cerebral blood flow after receiving DFO infusion.
Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.
Measured: baseline, 3hr, 6hr, 9hr
Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.
Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.
Measured: baseline, 3hr, 6hr, 9hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Farzaneh Sorond, Brigham and Women's Hospital
- Investigators
- Farzaneh Sorond, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365104
- Sponsor's protocol ID
- 1K23AG030967-01
- Other IDs
- 1K23AG030967-01A1
- Acronym
- DFO
- Status last verified
- Jan 2015
- First submitted
- 31 May 2011
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.
PubMed 26304864
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
- ClinicalTrials.gov ID
- NCT01365104
- Acronym / sponsor ID
- DFO / 1K23AG030967-01
- Conditions
- Stroke, Problem of Aging
- Keywords
- brain blood flow, stroke, cerebrovascular, aging, cerebrovascular hemodynamics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2011 (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 determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy young | Experimental | Drug: desferrioxamineEach subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other. |
| healthy old | Experimental | Drug: desferrioxamineEach subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults between the ages of 18-80 years.
Key exclusion criteria (24 listed)
- subjects taking vasoactive medications,
- hypertension,
- pregnant women, smokers,
- COPD,
- asthma,
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 |
|---|---|---|
| desferrioxamineAlso: Desferal, desferoxamineintravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg. | Drug | Healthy young, healthy old |
Primary outcome
Define change from baseline cerebral blood flow after receiving DFO infusion.
Time frame: baseline, 3hr, 6hr, 9hr
Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.
Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.
Time frame: baseline, 3hr, 6hr, 9hr
Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.
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 28 Jan 2015.
- Derived from this study: PubMed 26304864Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.
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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.
Farzaneh Sorond, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing desferrioxamine in people with Stroke and Problem of Aging, run by Brigham and Women's Hospital 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 24 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 28 Jan 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
Define change from baseline cerebral blood flow after receiving DFO infusion. (time frame: baseline, 3hr, 6hr, 9hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365104, which also lists 1 linked publication.
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 28 Jan 2015.