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Immunoglobulin A NephropathyPhase 2SPARTACUSNCT05856760

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

A Phase 2 study testing Sparsentan in people with Immunoglobulin A Nephropathy, run by Travere Therapeutics, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunoglobulin A Nephropathy
What is being tested?
Sparsentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
30 sitesin 2 countries
Study dates
19 May 2023to 25 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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/1.73m^2 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:
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  • The participant's maximum tolerated dose (MTD), and
  • at least one half of the maximum labeled dose (MLD)
  • Systolic BP must be ≤160 mmHg, and diastolic BP must be ≤110 mmHg at screening.
  • For participants receiving chronic low dose systemic corticosteroids (defined as ≤10 mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or a mineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeks prior to screening.

Who cannot join

  • 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.
  • Taking high dose (defined as >10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.
  • Has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalization for myocardial infarction unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularization procedure) within 3 months prior to screening.
  • Has jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or ALT and/or AST >2 times the ULN range at screening.
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  • Has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
  • Has a history of serious side effect or allergic response to any AngII antagonist, ERA or sparsentan, or has a hypersensitivity to any of the excipients in the study intervention.
  • Requires any of the prohibited concomitant medications.
  • Treatment with sparsentan within 12 weeks prior to screening
  • Has participated in a study of another investigational product within 28 days prior to screening or plans to participate in such a study during the course of this study.
  • Has a screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9 g/dL (90 g/L).
  • Has a screening potassium value of >5.5 mEq/L (5.5 mmol/L).
  • Is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
  • The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study intervention capsules whole.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States25 sites

  • Travere Investigational Site

    Albuquerque, New Mexico, 87109

  • Travere Investigational Site

    Birmingham, Alabama, 35233

  • Travere Investigational Site

    Boise, Idaho, 83706

  • Travere Investigational Site

    Chicago, Illinois, 60611

  • Travere Investigational Site

    Chubbuck, Idaho, 83202

  • Travere Investigational Site

    Chula Vista, California, 91910

  • Travere Investigation Site

    Clifton Park, New York, 12065

  • Travere Investigational Site

    Columbia, South Carolina, 29203

  • Travere Investigational Site

    Columbus, Ohio, 43210

  • Travere Investigational Site

    Dallas, Texas, 75230

  • Travere Investigational Site

    Dallas, Texas, 75246

  • Travere Investigational Site

    Denver, Colorado, 80230

  • Travere Investigational Site

    Evergreen Park, Illinois, 60805

  • Travere Investigational Site

    Fort Wayne, Indiana, 46804

  • Travere Investigational Site

    Fresh Meadows, New York, 11365

  • Travere Investigational Site

    Garden Grove, California, 92844

  • Travere Investigational Site

    Glendale, California, 91206

  • Travere Investigational Site

    Idaho Falls, Idaho, 83404

  • Travere Investigational Site

    Jacksonville, North Carolina, 28546

  • Travere Investigational Site

    Kansas City, Kansas, 66160

  • Travere Investigational Site

    Louisville, Kentucky, 40205

  • Travere Investigational Site

    New Bern, North Carolina, 28562

  • Travere Investigational Site

    New York, New York, 10013

  • Travere Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Travere Investigational Site

    Shreveport, Louisiana, 71101

Other trials in United States

Hong Kong5 sites

  • Travere Investigational Site

    Hong Kong

  • Travere Investigational Site

    Kowloon

  • Travere Investigational Site

    Shatin

  • Travere Investigational Site

    Sheung Wan

  • Travere Investigational Site

    Tsuen Wan

Other trials in Hong Kong

About this study

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 Immunoglobulin A Nephropathy (IgAN)

This was 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

Read the detailed description

This was 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 provided written informed consent were assessed for eligibility and underwent baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants were 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 continued their stable treatments through the screening period. Eligible participants discontinued ACEI and/or ARB therapy the day before the Day 1 visit and remained on stable SGLT2 inhibitor dosing for the duration of the study.

Study intervention was 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 was discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.

Being tested
Sparsentan
Keywords
IgAN
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SparsentanDrug

    Also called Filspari, RE-021

    Target dose of 400 mg daily

Study groups in NCT05856760
Study groupRoleWhat they receive
sparsentanExperimentalSparsentan 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.
Receives: Drug: Sparsentan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 24

Secondary outcomes (7)

  1. 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

    Measured: Week 24

  2. 30% Reduction From Baseline in UA/C at Week 24

    Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples

    Measured: Week 24

  3. 50% Reduction From Baseline in UA/C at Week 24

    Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples

    Measured: Week 24

  4. Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24

    The change from baseline in UP/C at Week 24 based on FMV samples

    Measured: Week 24

  5. Estimated Glomerular Filtration Rate (eGFR)

    Change from baseline estimated glomerular filtration rate at 24 weeks

    Measured: Week 24

  6. Systolic Blood Pressure (BP) at Week 24

    The change from baseline in systolic BP at Week 24

    Measured: Week 24

  7. Change in Diastolic Blood Pressure (BP)

    The change from baseline in diastolic BP at Week 24

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start19 May 2023
  3. Primary completion14 Oct 2024
  4. Study completion25 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856760
Sponsor's protocol ID
TVTX-RE021-204
Acronym
SPARTACUS
Status last verified
Sep 2025
First submitted
3 May 2023
Last updated
20 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sparsentan in people with Immunoglobulin A Nephropathy, run by Travere Therapeutics, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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