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

NCT04487301 | Completed

• 1 other identifier: SNFCT2020-07
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 7

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.

Conditions

Peripheral Artery Disease; End Stage Renal Disease on Dialysis

Keywords

PAD; Peripheral Artery Disease; End Stage Kidney Disease; End Stage Renal Disease; Dialysis

Outcome Measures

Primary Outcomes (12)

• 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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample of PAD-ESKD subjects

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanifit Therapeutics S. A.: lead

Study Sites (7)

Valley Renal Medical Group

Northridge, California, 91324, United States

Location

Horizon Medical Research

Coral Gables, Florida, 33134, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

St Louis Kidney Care

St Louis, Missouri, 63136, United States

Location

Mountain Kidney & Hypertension Associates

Asheville, North Carolina, 28801, United States

Location

Houston Medical Research

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Gold, MD

  Sanifit Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 27, 2020
• Study Start: November 16, 2020
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (7)