A Study to Investigate Safety & Effect of Sparsentan in Combination With

Status Recruiting

Clinical Trial Summary

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

Clinical Trial Description

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry. Participants who provide written informed consent will be assessed for eligibility and will undergo baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants are required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and will continue their stable treatments through the screening period. Eligible participants will discontinue ACEI and/or ARB therapy the day before the Day 1 visit and remain on stable SGLT2 inhibitor dosing for the duration of the study. Study intervention will be administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention will be discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05856760
Study type	Interventional
Source	Travere Therapeutics, Inc.
Contact	Travere Call Center
Phone	1-877-659-5518
Email	medinfo@travere.com
Status	Recruiting
Phase	Phase 2
Start date	May 19, 2023
Completion date	December 2024

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See also
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Completed	`NCT05200871` - Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
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Withdrawn	`NCT02605525` - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy	Phase 2
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Active, not recruiting	`NCT04573478` - Atrasentan in Patients With IgA Nephropathy	Phase 3
Active, not recruiting	`NCT03762850` - A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy	Phase 3
Active, not recruiting	`NCT04663204` - A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN — SPARTACUS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms