Peripheral Artery DiseaseNCT04487301
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
An observational study of Peripheral Artery Disease and End Stage Renal Disease on Dialysis, run by Sanifit Therapeutics S. A. at 7 sites in United States.
Trial summary
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Peripheral Artery Disease, End Stage Renal Disease on Dialysis
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Nov 2020to 12 Jun 2021
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of PAD-ESKD subjects
Who may be able to join
- ≥55 years of age or ≥45 years of age with diabetes
- Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
- Resting ABI <0.90 in either leg OR Resting TBI <0.70 in either leg
- Symptomatic as characterized by a limitation in exercise performance
Who cannot join
- Above-ankle amputation
- Chronic limb-threatening ischemia (Rutherford 4-6)
- Non-ambulatory status
- A condition other than PAD that limits ability to walk
- Open or endovascular revascularization within 3 months prior to baseline.
- Illnesses, conditions, or planned surgeries within the study period that will interfere with the interpretation of the study results
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Horizon Medical Research
Coral Gables, Florida, 33134
Houston Medical Research
Houston, Texas, 77004
Valley Renal Medical Group
Northridge, California, 91324
St Louis Kidney Care
St Louis, Missouri, 63136
About this study
Official title: A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
- Keywords
- PAD, Peripheral Artery Disease, End Stage Kidney Disease, End Stage Renal Disease, Dialysis
- Medical subject headings
- Peripheral Arterial Disease, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test
Walking distance in meters completed over a duration of 6 minutes
Measured: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.
Activity Patterns
Actigraphy measurements as 24 hour intervals of motion using an accelerometer device
Measured: Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.
Ankle Brachial Index
Compares blood pressure in upper extremities and lower extremities
Measured: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Toe Brachial Index
Compares blood pressure in upper extremities and lower extremities
Measured: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
San Diego Claudication Questionnaire
Will categorize the subject's perception of the leg symptoms associated with PAD
Measured: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
Walking Impairment Questionnaire
Will evaluate the subjects personal perception of walking ability.
Measured: Administered once during Week 1 during subject's participation of up to 4 weeks.
PAD Quality of Life
Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.
Measured: Administered once during Week 1 during subject's participation of up to 4 weeks.
EQ-SD-SL Health Questionnaire
Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Measured: Administered once during Week 1 during subject's participation of up to 4 weeks
Pulse Wave Velocity - Sub-Study
Measures arterial stiffness
Measured: Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.
Flow-Mediated Dilation - Sub-Study
Measures the ability of blood vessels to dilate
Measured: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Nitroglycerin-Medicated Dilation - Sub-Study
Measures the ability of blood vessels to dilate after administration of nitroglycerin
Measured: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Lower limb calcification measurements
A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.
Measured: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start16 Nov 2020
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanifit Therapeutics S. A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Gold, MD, Study director, Sanifit Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487301
- Sponsor's protocol ID
- SNFCT2020-07
- Status last verified
- Oct 2021
- First submitted
- 20 Jul 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Non-Interventional Study to Assess Walking Performance, Quality of Life, Vascular Function, and Lower Limb Arterial Calcification in Subjects With Peripheral Artery Disease and ESKD Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT04487301
- Acronym / sponsor ID
- SNFCT2020-07
- Keywords
- PAD, Peripheral Artery Disease, End Stage Kidney Disease, End Stage Renal Disease, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sanifit Therapeutics S. A.University, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- 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.
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of PAD-ESKD subjects
Key inclusion criteria (4 listed)
- ≥55 years of age or ≥45 years of age with diabetes
- Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
- Resting ABI <0.90 in either leg OR Resting TBI <0.70 in either leg
- Symptomatic as characterized by a limitation in exercise performance
Key exclusion criteria (6 listed)
- Above-ankle amputation
- Chronic limb-threatening ischemia (Rutherford 4-6)
- Non-ambulatory status
- A condition other than PAD that limits ability to walk
- Open or endovascular revascularization within 3 months prior to baseline.
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
Six Minute Walk Test
Time frame: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.
Walking distance in meters completed over a duration of 6 minutes
Activity Patterns
Time frame: Functional activity measurements will be collected daily beginning at the completion of screening and daily for the duration of the subject's participation of up to 4 weeks.
Actigraphy measurements as 24 hour intervals of motion using an accelerometer device
Ankle Brachial Index
Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Compares blood pressure in upper extremities and lower extremities
Toe Brachial Index
Time frame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
Compares blood pressure in upper extremities and lower extremities
San Diego Claudication Questionnaire
Time frame: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
Will categorize the subject's perception of the leg symptoms associated with PAD
Walking Impairment Questionnaire
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
Will evaluate the subjects personal perception of walking ability.
PAD Quality of Life
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks.
Will evaluate information about the subject's perception of social relationships, self-concepts and feelings, symptoms and limitations in physical functioning, fear and uncertainly, and positive adaptation.
EQ-SD-SL Health Questionnaire
Time frame: Administered once during Week 1 during subject's participation of up to 4 weeks
Will evaluate the subject's perception of overall health status, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Pulse Wave Velocity - Sub-Study
Time frame: Will be conducted once in a vascular lab for subjects participating the in the sub-study during Week 3 of the subjects participation of 4 weeks.
Measures arterial stiffness
Flow-Mediated Dilation - Sub-Study
Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Measures the ability of blood vessels to dilate
Nitroglycerin-Medicated Dilation - Sub-Study
Time frame: Will be conducted once in a vascular lab for subjects participating the in sub-study during Week 3 of the subjects participation of 4 weeks.
Measures the ability of blood vessels to dilate after administration of nitroglycerin
Lower limb calcification measurements
Time frame: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.
A non-contrast computed tomography scan of the lower extremities will be evaluated for arterial calcification.
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 14 Oct 2021.
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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.
Alex Gold, MD study director
Sanifit Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and End Stage Renal Disease on Dialysis, run by Sanifit Therapeutics S. A. at 7 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 4 inclusion and 6 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Six Minute Walk Test (time frame: Two six minute walk tests will be conducted separated by 5-7 days during Week 1 during the subject's participation of up to 4 weeks.). The study lists 12 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 14 Oct 2021.