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
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
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.
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 →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.
On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:
Exclusion Criteria:
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
Also known as: Filspari, RE-021
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
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
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
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
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
Estimated Glomerular Filtration Rate (eGFR)
Change from baseline estimated glomerular filtration rate at 24 weeks
Time frame: Week 24
Systolic Blood Pressure (BP) at Week 24
The change from baseline in systolic BP at Week 24
Time frame: Week 24
Change in Diastolic Blood Pressure (BP)
The change from baseline in diastolic BP at Week 24
Time frame: Week 24
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 \[4%\]).
| Milestone | Sparsentan |
|---|---|
| Started | 48 |
| Discontinued | 7 |
| Completed | 41 |
| Not completed | 7 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 3 |
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
| percent change | Sparsentan |
|---|---|
| Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 | -55.78 (-65.8 to -42.8) |
Achievement of UA/C of \<0.2 g/g at Week 24 based on FMV samples
| percentage of participants | Sparsentan |
|---|---|
| UA/C <0.2 g/g at Week 24 | 31 (17.0 to 47.6) |
Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples
| percentage of participants | Sparsentan |
|---|---|
| 30% Reduction From Baseline in UA/C at Week 24 | 77 (60.7 to 88.9) |
Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples
| percentage of participants | Sparsentan |
|---|---|
| 50% Reduction From Baseline in UA/C at Week 24 | 51 (34.8 to 67.6) |
The change from baseline in UP/C at Week 24 based on FMV samples
| percentage change | Sparsentan |
|---|---|
| Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24 | -45.20 (-54.6 to -33.9) |
Change from baseline estimated glomerular filtration rate at 24 weeks
| mL/min/1.73 square meter | Sparsentan |
|---|---|
| Estimated Glomerular Filtration Rate (eGFR) | -2.0 (-3.9 to -0.1) |
The change from baseline in systolic BP at Week 24
| mmHg | Sparsentan |
|---|---|
| Systolic Blood Pressure (BP) at Week 24 | -3.4 (-6.8 to 0.0) |
The change from baseline in diastolic BP at Week 24
| mmHg | Sparsentan |
|---|---|
| Change in Diastolic Blood Pressure (BP) | -4.6 (-6.7 to -2.4) |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sparsentan | 0/48 (0%) | 4/48 (8.3%) | 26/48 (54.2%) |
| Event | Sparsentan |
|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/48 |
| Cerebrovascular eventNervous system disorders | 1/48 |
| Acute kidney injuryRenal and urinary disorders | 1/48 |
| Deep vein thrombosisVascular disorders | 1/48 |
| Chemical burnInjury, poisoning and procedural complications | 1/48 |
| Event | Sparsentan |
|---|---|
| HypotensionVascular disorders | 7/48 |
| HeadacheNervous system disorders | 4/48 |
| OedemaGeneral disorders | 4/48 |
| Oedema peripheralGeneral disorders | 4/48 |
| Upper respiratory tract infectionInfections and infestations | 4/48 |
| DizzinessNervous system disorders | 3/48 |
| Age, Continuous(years) | Sparsentan |
|---|---|
| Median | 48 (19 to 78) |
| Sex: Female, Male(Participants) | Sparsentan |
|---|---|
| Female | 20 |
| Male | 28 |
| Race/Ethnicity, Customized(Participants) | Sparsentan |
|---|---|
| Race — White | 28 |
| Race — Black or African American | 1 |
| Race — Asian | 19 |
| Race/Ethnicity, Customized(Participants) | Sparsentan |
|---|---|
| Ethnicity — Hispanic or Latino | 5 |
| Ethnicity — Not Hispanic or Latino | 42 |
| Ethnicity — Not Reported | 1 |
| Region of Enrollment(participants) | Sparsentan |
|---|---|
| Hong Kong | 11 |
| United States | 37 |
| Height(centimeters) | Sparsentan |
|---|---|
| Mean | 168.2 ± 11.16 |
| Weight(Kilograms) | Sparsentan |
|---|---|
| Mean | 85.9 ± 22.25 |
| BMI(kg/m^2) | Sparsentan |
|---|---|
| Mean | 30.02 ± 5.619 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Travere Therapeutics, Inc.