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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04487301
Other study ID # SNFCT2020-07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2020
Est. completion date June 12, 2021

Study information

Verified date October 2021
Source Sanifit Therapeutics S. A.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 12, 2021
Est. primary completion date June 12, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mountain Kidney & Hypertension Associates Asheville North Carolina
United States Boston Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Horizon Medical Research Coral Gables Florida
United States Houston Medical Research Houston Texas
United States Valley Renal Medical Group Northridge California
United States St Louis Kidney Care Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Sanifit Therapeutics S. A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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
Primary 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
Primary 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.
Primary 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.
Primary 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.
Primary 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
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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