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Can a longer course of TARPEYO tame kidney disease?

NCT ID NCT06712407

Disease control Sponsor: Calliditas Therapeutics AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether taking TARPEYO (budesonide) for a longer period helps adults with IgA nephropathy, a kidney disease. Participants have already taken the drug for 9 months and will now take it for another 15 months. The main goal is to see if protein levels in urine stay lower, which would suggest less kidney damage.

What this could mean

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

Active substance
budesonide (delayed-release capsules)
What this could lead to
If successful, this could show that taking TARPEYO for a longer period helps control kidney damage in IgA nephropathy, potentially reducing the need for more aggressive treatments.
What could go wrong
This is a small, early-phase 4 study with only 60 participants, so results may not apply to everyone. The drug may not provide additional benefit beyond the initial 9 months, and side effects from long-term steroid use are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

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: 1. Diagnosed IgAN with biopsy verification 2. Female or male participants ≥18 years of age 3. Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit 4. Access to retrospective local laboratory assessment data on UPCR and serum creatinine. Available retrospective data should include at least 1 assessment timepoint within 3 months prior to the first dose of TARPEYO® commercial treatment. 5. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy or sparsentan for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline. 6. If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, the treatment should have been stable for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline. Exclusion Criteria: 1. Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO® commercial treatment period. Topical or inhalation products containing GCS or immunosuppressants are allowed. 2. Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy). 3. Presence of nephrotic syndrome (i.e., proteinuria \>3.5 g per day and serum albumin \<3.0 g/dL, with or without edema). 4. Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator. 5. On current or planned dialysis. 6. Undergone kidney transplant. 7. Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator. 8. Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations. 9. Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator. 10. Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator. 11. Participants unwilling or unable to meet the requirements of the protocol. 12. Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period. 13. Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period. 14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4

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Conditions

The condition(s) this trial relates to.

chronic kidney disease IgA glomerulonephritis

As listed by the trial registrant

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

IgA nephropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Renal Care Institute

    RECRUITING

    Mayagüez, 00680, Puerto Rico

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Central Florida Kidney Specialists

    RECRUITING

    Orlando, Florida, 32819, United States

  • Chinatown Kidney Care, PLLC

    RECRUITING

    New York, New York, 10013, United States

  • Cobb Nephrology Hypertension Associates, PC

    RECRUITING

    Austell, Georgia, 30106, United States

  • Dallas Nephrology Associates McKinney

    RECRUITING

    McKinney, Texas, 75069, United States

  • Dallas Renal Group

    RECRUITING

    Dallas, Texas, 75230, United States

  • Florida Kidney Physicians

    RECRUITING

    Boca Raton, Florida, 33431, United States

  • Georgia Nephrology

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Loma Linda University

    RECRUITING

    San Bernardino, California, 92408, United States

  • MedResearch Inc

    RECRUITING

    El Paso, Texas, 79902, United States

  • Memorial Hermann Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • New York Nephrology Vasculitis and Glomerular Center

    RECRUITING

    Clifton Park, New York, 12065, United States

  • North Carolina Nephrology, P.A

    RECRUITING

    Raleigh, North Carolina, 27609, United States

  • Ochsner Health, New Orleans

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic

    RECRUITING

    Portland, Oregon, 97239, United States

  • Permian Basin Kidney Center

    RECRUITING

    Odessa, Texas, 79761, United States

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Renal Medical Associates

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Southeastern Clinical Research Institute, LLC

    RECRUITING

    Augusta, Georgia, 30904, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • The Kidney Institute/Houston

    RECRUITING

    Houston, Texas, 77090, United States

  • The Medical Research Group, Inc.

    RECRUITING

    Fresno, California, 93720, United States

  • The University of Texas Medical Branch UTMB

    RECRUITING

    Galveston, Texas, 77555, United States

  • UCI Health-UCI Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice

    RECRUITING

    San Francisco, California, 94143, United States

  • Univ of Alabama/Birmingham

    RECRUITING

    Birmingham, Alabama, 35297, United States

  • University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40208, United States

  • University of Maryland Division of Nephrology

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Minnesota Health Fairview

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Pennsylvania Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Yale University Nephrology Clinical Trials Program

    RECRUITING

    New Haven, Connecticut, 06510, United States

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