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ProteinuriaPhase 4SPARXNCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

A Phase 4 study testing Sparsentan in people with Proteinuria and Immunoglobulin A (IgA) Nephropathy, run by Travere Therapeutics, Inc. at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the safety and efficacy of sparsentan tablets for the treatment of patients with proteinuria after kidney transplantation with once-daily dosing for 36 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sparsentan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesUnited States
Study dates
7 Oct 2025to May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

  • Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • Male and female aged ≥18 years
  • Participants with a kidney transplant with biopsy-proven IgAN or FSGS histological pattern in the graft.
  • A period of ≥12 months since kidney transplantation.
  • UPCR ≥0.5 g/g and eGFR (CKD-EPI creatinine-based formula ≥30 mL/min/1.73 m2.
  • Participants who can become pregnant, must agree to the use of 1 highly reliable method of contraception from 7 days prior to the first dose of study intervention until 30 days after the last dose of study intervention.
  • Systolic BP ≤160 mmHg and ≥100 mmHg, and diastolic BP ≤100 mmHg and ≥60 mmHg at screening.
  • For participants on an ACEI and/or ARB, and/or sodium glucose cotransporter-2 (SGLT2) inhibitor, the dosing regimen(s) is stable for ≥6 weeks prior to screening.

Who cannot join

  • Participant has multiorgan transplants (with the exception of pancreas and corneal transplants).
  • Immunosuppressive therapy (IST) regimen for kidney transplant or other systemic chronic ISTs including enteric budesonide that is not stable for >6 weeks prior to Day 1. Exceptions include routine changes in the dose of CNIs to meet target level.
  • <3 months after antirejection treatment and active rejection.
  • Active bacterial, fungal or viral infection and/or active treatment of infection including BK virus (BKV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B and C <3 months prior to and during the screening period.
  • Current treatment for surgical complications.
  • History of heart failure (New York Heart Association [NYHA] Class II-IV).
Show all 17Show fewer
  • Jaundice, hepatitis, or known hepatobiliary disease.
  • Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence.
  • History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
  • History of serious side effects or allergic response to any angiotensin II antagonist or ERA.
  • Participant requires any of the prohibited concomitant medications.
  • Treatment with sparsentan <12 weeks prior to screening.
  • Participant has participated in a study of another investigational product <28 days prior to screening or plans to participate in such a study during the course of this study.
  • Hematocrit <27%, hemoglobin <90 g/L (9 g/dL), or potassium >5.5 mmol/L (5.5 mEq/L).
  • The participant 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 IMP whole.
  • The participant, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Ohio State University

    Columbus, Ohio, 43210

  • Dallas Nephrology Associates

    Dallas, Texas, 75204

  • University of Texas

    Galveston, Texas, 27599

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • University of North Carolina Chapel Hill

    Morrisville, North Carolina, 27560

  • Cornell Medical Center

    New York, New York, 10065

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Multicenter, Open-label Single Arm Study to Evaluate the Safety and Efficacy of Sparsentan in Posttransplant Immunoglobulin A Nephropathy (IgAN) or Focal Segmental Glomerulosclerosis (FSGS) (SPARX)

To evaluate the safety and efficacy of sparsentan tablets for the treatment of patients with proteinuria after kidney transplantation with once-daily dosing for 36 weeks.

Read the detailed description

This is a 46-week, open-label, multicenter, single-group Phase 4 study to determine the safety and efficacy of sparsentan for the treatment of patients post kidney transplantation with IgAN or FSGS with proteinuria (≥ 0.5 g/g).

Eligible participants with a kidney transplant receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (IST) to prevent graft rejection, will be enrolled to receive sparsentan treatment for 36 weeks. Participants will remain on standard IST for the duration of the study and will stop RAASi prior to initiating sparsentan treatment. The final dose of a RAASi should be taken on the day before the Day 1 visit.

Participants with a kidney transplant, at least one year prior to screening, with biopsy-proven IgAN will take 200 mg orally once daily (QD) for 2 weeks, then 400 mg QD through Week 36. Participants with a kidney transplant with FSGS histological pattern in the graft, or a biopsy finding of both IgAN and glomeruli with FSGS patterns will take 400 mg orally QD for 2 weeks, then 800 mg QD through Week 36.

Study visits will be conducted at Day 5 and Weeks 2, 4, 6, 12, 24, and 36 following Day 1. Following the 36 week treatment period, all participants will complete a 4 week off-sparsentan treatment follow-up period (ie, no study drug), during which time treatment will be at the discretion of the investigator. Participants will have a telephone visit at Week 40.

Being tested
Sparsentan
Keywords
IgAN, FSGS, kidney transplant, proteinuria
Medical subject headings
Proteinuria, Kidney Diseases, Glomerulosclerosis, Focal Segmental

What participants receive

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

  • SparsentanDrug

    For participants with a kidney transplant with IgAN:

    Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.

    For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns:

    Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.

Study groups in NCT07219121
Study groupRoleWhat they receive
Drug: SparsentanExperimentalA non-immunosuppressive single molecule with dual antagonism of ETAR and AT1R, has shown potent anti-proteinuric effect in patients with native kidney disease, including IgAN and FSGS.
Receives: Drug: Sparsentan

What is being measured

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

  1. Urinary protein/creatinine ratio (UPCR)

    Change from baseline (Day 1) in urinary protein/creatinine ratio (UPCR) to Week 36.

    Measured: 36 weeks

Secondary outcomes (6)

  1. Change from baseline in UPCR

    Change from baseline in UPCR each visit.

    Measured: 36 weeks

  2. Urinary albumin/creatinine ratio (UACR)

    Change from baseline in UACR at each visit

    Measured: 36 weeks

  3. Change from baseline in eGFR (estimated glomerular filtration rate)

    Change from baseline in eGFR, applying creatinine and cystatin C based formulae, at each visit

    Measured: 36 weeks

  4. Change from baseline in blood pressure (BP)

    Change in systolic and diastolic BP at each visit

    Measured: 36 weeks

  5. Achievement of UPCR <0.3 g/g

    Achievement of UPCR <0.3 g/g at Weeks 12, 24 and 36

    Measured: 36 weeks

  6. 30% and 50% reductions in UPCR

    The proportion of participants achieving 30% and 50% reductions in UPCR at Week 36.

    Measured: 36 weeks

Timeline

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

  1. First posted21 Oct 2025
  2. Study start7 Oct 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
46-week, open-label, multicenter, single-group Phase 4 study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07219121
Sponsor's protocol ID
TVTX-RE021-426
Acronym
SPARX
Status last verified
Jun 2026
First submitted
9 Oct 2025
Last updated
23 Jun 2026
Results posted
No
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 4 study testing Sparsentan in people with Proteinuria and Immunoglobulin A (IgA) Nephropathy, run by Travere Therapeutics, Inc. at 8 sites in United States.

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 8 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Urinary protein/creatinine ratio (UPCR) (time frame: 36 weeks). 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 NCT07219121.

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 23 Jun 2026.

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