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New drug cocktail shows promise for slowing kidney disease

NCT ID NCT05856760

Disease control Sponsor: Travere Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding sparsentan to a standard SGLT2 inhibitor can better protect kidneys in people with IgA nephropathy, a disease that can lead to kidney failure. 48 adults who were already on stable doses of both a blood pressure drug and an SGLT2 inhibitor took sparsentan for 28 weeks. Researchers measured changes in urine protein levels to see if kidney damage slowed down.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sparsentan (also called Filspari) combined with an SGLT2 inhibitor (a type of diabetes drug that also protects kidneys)
What this could lead to
If it works, this combination could offer a new way to slow kidney damage and delay kidney failure in people with IgA nephropathy.
What could go wrong
This is a small, early-phase study with no placebo group, so results may not be definitive. The combination may not prove more effective than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Started

May 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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.

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Travere Investigation Site

    Clifton Park, New York, 12065, United States

  • 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 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

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