A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; End Stage Renal Disease on Dialysis

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • California
    • Northridge, California, United States, 91324
      • Valley Renal Medical Group
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Horizon Medical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St Louis Kidney Care
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mountain Kidney & Hypertension Associates
  • Texas
    • Houston, Texas, United States, 77004
      • Houston Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community sample of PAD-ESKD subjects

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test	Walking distance in meters completed over a duration of 6 minutes	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	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	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	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	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.	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.	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.	Administered once during Week 1 during subject's participation of up to 4 weeks
Pulse Wave Velocity - Sub-Study	Measures arterial stiffness	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	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	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.	Will be conducted once in subjects participating the in sub-study during Week 3 of the subjects participation of up to 4 weeks.

Collaborators and Investigators

• Sponsor: Sanifit Therapeutics S. A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ACTUAL): June 12, 2021
• Study Completion (ACTUAL): June 12, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (ACTUAL): July 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: PAD; End Stage Renal Disease; Peripheral Artery Disease; Dialysis; End Stage Kidney Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Renal Insufficiency; Atherosclerosis; Renal Insufficiency, Chronic; Peripheral Vascular Diseases; Kidney Diseases; Peripheral Arterial Disease; Kidney Failure, Chronic
• Other Study ID Numbers: SNFCT2020-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No