Clinical Trial

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

Study acronym: SPARVASC
Active, Not Recruiting Phase 2
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Summary
ANCA-associated vasculitis is an autoimmune disease that causes damage to blood vessels. This leads to organ damage with the number of organs affected and the severity of damage varying significantly between patients. Vasculitis patients also have a very high risk of heart attacks and strokes, called cardiovascular disease. A chemical called 'endothelin', produced by the blood vessels, causes vessels to stiffen and raises blood pressure and this associates with cardiovascular risk. The investigators have previously shown that by blocking the effects of endothelin you reduce vessel stiffness, lower blood pressure and improve vessel function. However, these studies only blocked endothelin for a few hours. Now, the investigators would like to see if it is possible to maintain these benefits by blocking endothelin for longer. Sparsentan is a tablet that blocks endothelin and lowers blood pressure. The investigators plan to give sparsentan to patients with vasculitis for 6 weeks. To determine if any beneficial effects of sparsentan are due to blood pressure lowering the investigators will give another group of vasculitis patients a tablet called irbesartan which lowers blood pressure but does not block endothelin. The investigators will compare the results between the two groups.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-11-18; most recent amendment 2025-08-18.
Status change: Recruiting → Active, Not Recruiting 2024-07-25
Trial Details
NCT Number NCT05630612
Lead Sponsor University of Edinburgh
Collaborators: Travere Therapeutics, Inc.
Conditions ANCA Associated Vasculitis, Cardiovascular Diseases, Kidney Diseases
Enrollment 32 participants
Start Date 2022-12-08
Primary Completion 2024-07-18 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-24