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

Immunoglobulin A Nephropathy Clinical Trial

— SPARTACUS  

Official title:

A Multicentered, Single-group Phase 2, Exploratory, Open-label Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in the Treatment of Adult Participants With IgAN

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856760
• Other study ID #: TVTX-RE021-204
• Status: Recruiting
• Phase: Phase 2
• Start date: May 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Travere Therapeutics, Inc.
• Contact: Travere Call Center
• Phone: 1-877-659-5518
• Email: medinfo[@]travere.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• UA/C =0.3 g/g at screening

• An eGFR value of =25 mL/min/1.73m2 at screening.

• On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.

• On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:

• 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.

• Undergone any organ transplant, with the exception of corneal transplants.

• Documented history of heart failure, clinically significant cardiovascular or liver disease.

• Taking high dose (defined as >10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy

Intervention

Drug:
• Sparsentan
Target dose of 400 mg daily

Locations

Country	Name	City	State
Hong Kong	Travere Investigational Site	Hong Kong
Hong Kong	Travere Investigational Site	Kowloon
Hong Kong	Travere Investigational Site	Shatin
Hong Kong	Travere Investigational Site	Sheung Wan
Hong Kong	Travere Investigational Site	Tsuen Wan
United States	Travere Investigational Site	Albuquerque	New Mexico
United States	Travere Investigational Site	Birmingham	Alabama
United States	Travere Investigational Site	Boise	Idaho
United States	Travere Investigational Site	Chicago	Illinois
United States	Travere Investigational Site	Chubbuck	Idaho
United States	Travere Investigational Site	Chula Vista	California
United States	Travere Investigation SIte	Clifton Park	New York
United States	Travere Investigational Site	Columbia	South Carolina
United States	Travere Investigational Site	Columbus	Ohio
United States	Travere Investigational Site	Dallas	Texas
United States	Travere Investigational Site	Dallas	Texas
United States	Travere Investigational Site	Denver	Colorado
United States	Travere Investigational Site	Evergreen Park	Illinois
United States	Travere Investigational Site	Fort Wayne	Indiana
United States	Travere Investigational Site	Fresh Meadows	New York
United States	Travere Investigational Site	Garden Grove	California
United States	Travere Investigational Site	Glendale	California
United States	Travere Investigational Site	Idaho Falls	Idaho
United States	Travere Investigational Site	Jacksonville	North Carolina
United States	Travere Investigational Site	Kansas City	Kansas
United States	Travere Investigational Site	Louisville	Kentucky
United States	Travere Investigational Site	Nampa	Idaho
United States	Travere Investigational Site	New Bern	North Carolina
United States	Travere Investigational Site	New York	New York
United States	Travere Investigational Site	Philadelphia	Pennsylvania
United States	Travere Investigational Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Travere Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine albumin-creatinine ratio (UA/C) at Week 24	The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples	Week 24
Secondary	UA/C <0.2 g/g at Week 24	Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples	Week 24
Secondary	30% and 50% reduction from baseline in UA/C at Week 24	Achievement of 30% and 50% reduction from baseline in UA/C at Week 24 based on FMV samples	Week 24
Secondary	UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit	Change from baseline in UA/C and UP/C at each visit based on FMV samples	Week 24
Secondary	Estimated glomerular filtration rate (eGFR) at each visit	Change from baseline eGFR at each visit	Week 24
Secondary	Blood pressure (BP) at each visit	Change from baseline systolic and diastolic BP at each visit.	Week 24

External Links

•   Sponsor Website