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

February 22, 2024 updated by: Travere Therapeutics, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Travere Investigational Site
      • Kowloon, Hong Kong
        • Recruiting
        • Travere Investigational Site
      • Shatin, Hong Kong
        • Recruiting
        • Travere Investigational Site
      • Sheung Wan, Hong Kong
        • Recruiting
        • Travere Investigational Site
      • Tsuen Wan, Hong Kong
        • Recruiting
        • Travere Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Travere Investigational Site
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Travere Investigational Site
      • Garden Grove, California, United States, 92844
        • Completed
        • Travere Investigational Site
      • Glendale, California, United States, 91206
        • Recruiting
        • Travere Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Travere Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Travere Investigational Site
      • Chubbuck, Idaho, United States, 83202
        • Recruiting
        • Travere Investigational Site
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Travere Investigational Site
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Travere Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Travere Investigational Site
      • Evergreen Park, Illinois, United States, 60805
        • Recruiting
        • Travere Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Travere Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Travere Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Travere Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Recruiting
        • Travere Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Travere Investigational Site
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • Travere Investigation SIte
      • Fresh Meadows, New York, United States, 11365
        • Recruiting
        • Travere Investigational Site
      • New York, New York, United States, 10013
        • Recruiting
        • Travere Investigational Site
    • North Carolina
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Travere Investigational Site
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • Travere Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Travere Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Travere Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Travere Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Travere Investigational Site
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Travere Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • RE-021
  • Filspari

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine albumin-creatinine ratio (UA/C) at Week 24
Time Frame: Week 24
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UA/C <0.2 g/g at Week 24
Time Frame: Week 24
Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples
Week 24
30% and 50% reduction from baseline in UA/C at Week 24
Time Frame: Week 24
Achievement of 30% and 50% reduction from baseline in UA/C at Week 24 based on FMV samples
Week 24
UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit
Time Frame: Week 24
Change from baseline in UA/C and UP/C at each visit based on FMV samples
Week 24
Estimated glomerular filtration rate (eGFR) at each visit
Time Frame: Week 24
Change from baseline eGFR at each visit
Week 24
Blood pressure (BP) at each visit
Time Frame: Week 24
Change from baseline systolic and diastolic BP at each visit.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Travere Therapeutics, Inc.

Investigators

  • Study Director: Priscila Preciado, MD, Travere Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVTX-RE021-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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