Clinical trial NCT04487301: A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
End Stage Renal Disease on Dialysis
Keywords: PAD
Peripheral Artery Disease
End Stage Kidney Disease
End Stage Renal Disease
Dialysis
Lead sponsor: Sanifit Therapeutics S. A.
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample of PAD-ESKD subjects

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: 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.
measure: Activity Patterns
timeFrame: 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.
measure: Ankle Brachial Index
timeFrame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
measure: Toe Brachial Index
timeFrame: Will be conducted once in a vascular laboratory during the screening visit or visits during the subject's participation of up to 4 weeks
measure: San Diego Claudication Questionnaire
timeFrame: Administered once during Day 1 of the screening visit during subject's participation of up to 4 weeks.
measure: Walking Impairment Questionnaire
timeFrame: Administered once during Week 1 during subject's participation of up to 4 weeks.
measure: PAD Quality of Life
timeFrame: Administered once during Week 1 during subject's participation of up to 4 weeks.
measure: EQ-SD-SL Health Questionnaire
timeFrame: Administered once during Week 1 during subject's participation of up to 4 weeks
measure: Pulse Wave Velocity - Sub-Study
timeFrame: 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.
measure: Flow-Mediated Dilation - Sub-Study
timeFrame: 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.
measure: Nitroglycerin-Medicated Dilation - Sub-Study
timeFrame: 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.
measure: Lower limb calcification measurements
timeFrame: Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Coral Gables
country: United States
facility: Horizon Medical Research
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: St Louis Kidney Care
state: Missouri
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates
state: North Carolina
city: Houston
country: United States
facility: Houston Medical Research
state: Texas
Study officials:
affiliation: Sanifit Therapeutics
name: Alex Gold, MD
role: STUDY_DIRECTOR
References: