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CompletedNCT05856760SPARTACUSUpdated Nov 20, 2025Results posted

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

A Phase 2 interventional study of Sparsentan in Immunoglobulin A Nephropathy, sponsored by Travere Therapeutics, Inc.. Completed at 30 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Travere Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Immunoglobulin A Nephropathy

Keywords

  • IgAN
03

In context

Glomerulonephritis, IGA

254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.

This study's enrollment of 48 is below the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Travere Therapeutics, Inc. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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/1.73m\^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:

    • 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.

Exclusion criteria

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.
  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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

Interventions

  • DrugSparsentan

    Target dose of 400 mg daily

    Also known as: Filspari, RE-021

06

What researchers measure

Primary outcomes

  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

    Time frame: Week 24

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Week 24

  5. Estimated Glomerular Filtration Rate (eGFR)

    Change from baseline estimated glomerular filtration rate at 24 weeks

    Time frame: Week 24

  6. Systolic Blood Pressure (BP) at Week 24

    The change from baseline in systolic BP at Week 24

    Time frame: Week 24

  7. Change in Diastolic Blood Pressure (BP)

    The change from baseline in diastolic BP at Week 24

    Time frame: Week 24

07

Results

Posted Nov 20, 2025

Participant flow

Forty-eight participants were enrolled in the study and all 48 (100%) received at least 1 dose of sparsentan. Sparsentan was prematurely discontinued in 9 participants (19%). Forty-one participants (85%) completed the study, and 7 participants (15%) discontinued the study. The most common reasons for discontinuation from the study were withdrawal by participant (3 participants \[6%\]) and AEs (2 participants \[4%\]).

Participant flow — Overall Study
MilestoneSparsentan
Started48
Discontinued7
Completed41
Not completed7
Withdrew: Adverse event2
Withdrew: Physician decision1
Withdrew: Protocol violation1
Withdrew: Withdrawal by subject3

Outcome measures

PrimaryChange 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

Time frame:
Week 24
Reported as:
Least squares mean · percent change
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24
percent changeSparsentan
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24-55.78 (-65.8 to -42.8)
SecondaryUA/C <0.2 g/g at Week 24

Achievement of UA/C of \<0.2 g/g at Week 24 based on FMV samples

Time frame:
Week 24
Reported as:
Number · percentage of participants
UA/C <0.2 g/g at Week 24
percentage of participantsSparsentan
UA/C <0.2 g/g at Week 2431 (17.0 to 47.6)
Secondary30% 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

Time frame:
Week 24
Reported as:
Number · percentage of participants
30% Reduction From Baseline in UA/C at Week 24
percentage of participantsSparsentan
30% Reduction From Baseline in UA/C at Week 2477 (60.7 to 88.9)
Secondary50% 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

Time frame:
Week 24
Reported as:
Number · percentage of participants
50% Reduction From Baseline in UA/C at Week 24
percentage of participantsSparsentan
50% Reduction From Baseline in UA/C at Week 2451 (34.8 to 67.6)
SecondaryChange 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

Time frame:
Week 24
Reported as:
Least squares mean · percentage change
Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24
percentage changeSparsentan
Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24-45.20 (-54.6 to -33.9)
SecondaryEstimated Glomerular Filtration Rate (eGFR)

Change from baseline estimated glomerular filtration rate at 24 weeks

Time frame:
Week 24
Reported as:
Geometric mean · mL/min/1.73 square meter
Estimated Glomerular Filtration Rate (eGFR)
mL/min/1.73 square meterSparsentan
Estimated Glomerular Filtration Rate (eGFR)-2.0 (-3.9 to -0.1)
SecondarySystolic Blood Pressure (BP) at Week 24

The change from baseline in systolic BP at Week 24

Time frame:
Week 24
Reported as:
Least squares mean · mmHg
Systolic Blood Pressure (BP) at Week 24
mmHgSparsentan
Systolic Blood Pressure (BP) at Week 24-3.4 (-6.8 to 0.0)
SecondaryChange in Diastolic Blood Pressure (BP)

The change from baseline in diastolic BP at Week 24

Time frame:
Week 24
Reported as:
Least squares mean · mmHg
Change in Diastolic Blood Pressure (BP)
mmHgSparsentan
Change in Diastolic Blood Pressure (BP)-4.6 (-6.7 to -2.4)

Adverse events

Collected over 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sparsentan0/48 (0%)4/48 (8.3%)26/48 (54.2%)
Most frequent serious events
Most frequent serious events
EventSparsentan
OsteoarthritisMusculoskeletal and connective tissue disorders1/48
Cerebrovascular eventNervous system disorders1/48
Acute kidney injuryRenal and urinary disorders1/48
Deep vein thrombosisVascular disorders1/48
Chemical burnInjury, poisoning and procedural complications1/48
Most frequent other events
Most frequent other events
EventSparsentan
HypotensionVascular disorders7/48
HeadacheNervous system disorders4/48
OedemaGeneral disorders4/48
Oedema peripheralGeneral disorders4/48
Upper respiratory tract infectionInfections and infestations4/48
DizzinessNervous system disorders3/48

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sparsentan
Median48 (19 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Sparsentan
Female20
Male28
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Sparsentan
Race — White28
Race — Black or African American1
Race — Asian19
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Sparsentan
Ethnicity — Hispanic or Latino5
Ethnicity — Not Hispanic or Latino42
Ethnicity — Not Reported1
Region of Enrollment
Region of Enrollment(participants)Sparsentan
Hong Kong11
United States37
Height
Height(centimeters)Sparsentan
Mean168.2 ± 11.16
Weight
Weight(Kilograms)Sparsentan
Mean85.9 ± 22.25
BMI
BMI(kg/m^2)Sparsentan
Mean30.02 ± 5.619

3 further baseline measures are reported on the registry.

08

Study locations

30 sites
  • Travere Investigational Site
    Birmingham, Alabama 35233, United States
  • Travere Investigational Site
    Chula Vista, California 91910, United States
  • Travere Investigational Site
    Garden Grove, California 92844, United States
  • Travere Investigational Site
    Glendale, California 91206, United States
  • Travere Investigational Site
    Denver, Colorado 80230, United States
  • Travere Investigational Site
    Boise, Idaho 83706, United States
  • Travere Investigational Site
    Chubbuck, Idaho 83202, United States
  • Travere Investigational Site
    Idaho Falls, Idaho 83404, United States
  • Travere Investigational Site
    Chicago, Illinois 60611, United States
  • Travere Investigational Site
    Evergreen Park, Illinois 60805, United States
  • Travere Investigational Site
    Fort Wayne, Indiana 46804, United States
  • Travere Investigational Site
    Kansas City, Kansas 66160, United States
  • Travere Investigational Site
    Louisville, Kentucky 40205, United States
  • Travere Investigational Site
    Shreveport, Louisiana 71101, United States
  • Travere Investigational Site
    Albuquerque, New Mexico 87109, United States
  • Travere Investigation Site
    Clifton Park, New York 12065, United States
  • Travere Investigational Site
    Fresh Meadows, New York 11365, United States
  • Travere Investigational Site
    New York, New York 10013, United States
  • Travere Investigational Site
    Jacksonville, North Carolina 28546, United States
  • Travere Investigational Site
    New Bern, North Carolina 28562, United States
  • Travere Investigational Site
    Columbus, Ohio 43210, United States
  • Travere Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • Travere Investigational Site
    Columbia, South Carolina 29203, United States
  • Travere Investigational Site
    Dallas, Texas 75230, United States
  • Travere Investigational Site
    Dallas, Texas 75246, United States
  • 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, Hong Kong
09

References and documents

Related links

Study documents

  • Study protocol · Feb 21, 2023
  • Statistical analysis plan · Jun 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05856760
Lead sponsor
Travere Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 12, 2023
Start date
May 19, 2023
Primary completion
Oct 14, 2024
Completion
Oct 25, 2024
Results posted
Nov 20, 2025
Last update
Nov 20, 2025

Study contacts

Radko Komers, MD, PhD
study director · Travere Therapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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