SPARTACUS: A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sparsentan Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2. |
Drug: Sparsentan
Target dose of 400 mg daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in urine albumin-creatinine ratio (UA/C) at Week 24 [Week 24]
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
Secondary Outcome Measures
- UA/C <0.2 g/g at Week 24 [Week 24]
Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples
- 30% and 50% reduction from baseline in UA/C at Week 24 [Week 24]
Achievement of 30% and 50% reduction from baseline in UA/C at Week 24 based on FMV samples
- UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit [Week 24]
Change from baseline in UA/C and UP/C at each visit based on FMV samples
- Estimated glomerular filtration rate (eGFR) at each visit [Week 24]
Change from baseline eGFR at each visit
- Blood pressure (BP) at each visit [Week 24]
Change from baseline systolic and diastolic BP at each visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged ≥18 years at the time of signing the informed consent.
-
Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.
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UA/C ≥0.3 g/g at screening
-
An eGFR value of ≥25 mL/min/1.73m2 at screening.
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On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.
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On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:
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The participant's maximum tolerated dose (MTD), and
-
at least one half of the maximum labeled dose (MLD)
Exclusion Criteria:
-
IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.
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Undergone any organ transplant, with the exception of corneal transplants.
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Documented history of heart failure, clinically significant cardiovascular or liver disease.
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Taking high dose (defined as >10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Travere Investigational Site | Denver | Colorado | United States | 80230 |
Sponsors and Collaborators
- Travere Therapeutics, Inc.
Investigators
- Study Director: Priscila Preciado, MD, Travere Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TVTX-RE021-204