Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

Last updated: January 27, 2026
Sponsor: Calliditas Therapeutics AB
Overall Status: Active - Recruiting

Phase

4

Condition

Glomerulonephritis

Nephropathy

Kidney Disease

Treatment

TARPEYO®

Clinical Study ID

NCT06712407
Nef-403
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is:

Is there a treatment benefit of TARPEYO® 16 mg QD extended use?

Participants will

  • take part in this study for about 19 months

  • Have urine tests done

  • Have blood samples taken

  • Have physical examinations done

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed IgAN with biopsy verification

  2. Female or male participants ≥18 years of age

  3. Completion of 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit

  4. Access to retrospective local laboratory assessment data on UPCR and serumcreatinine. Available retrospective data should include at least 1 assessment timepoint within 3months prior to the first dose of TARPEYO® commercial treatment

  5. Proteinuria at Screening based on 2 consecutive measurements (24-hour urinecollection) after informed consent, separated by at least 1 week and calculated bythe central laboratory. Both samples of the same parameter must show either of the following:

  • Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or

  • UPCR ≥0.3 g/gram in 2 consecutive measurements

  1. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy for atleast 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline

  2. If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, thetreatment 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

Exclusion Criteria:

  1. Participants who have been treated with systemic immunosuppressive medicationsincluding glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO®commercial treatment period. Topical or inhalation products containing GCS orimmunosuppressants are allowed

  2. Presence of other glomerulopathies (e.g., C3 glomerulopathy and/or diabetesnephropathy)

  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 bythe Investigator

  5. On current or planned dialysis.

  6. Undergone kidney transplant.

  7. Poorly controlled diabetes mellitus or hypertension, as assessed by theInvestigator.

  8. Participants with known osteoporosis in the medium- or high-risk category accordingto 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 atrisk, 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 trialperiod.

  14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: TARPEYO®
Phase: 4
Study Start date:
December 17, 2024
Estimated Completion Date:
November 30, 2027

Study Description

This clinical trial will investigate the efficacy and safety of TARPEYO® treatment extended for an additional 15 months in adult IgAN participants who have completed their 9-month TARPEYO® 16 mg QD commercial treatment regimen. Participants with residual proteinuria will be eligible for enrollment. The Treatment Period will consist of a 6-month Treatment Period with TARPEYO® 16 mg QD, followed by a 9-month Treatment Period with TARPEYO® 8 mg QD. This will be followed by a 3-month Follow-up Period, which includes the first 2 weeks of Tapering Period with TARPEYO® 4 mg QD.

The overall aim of the extended treatment is to improve and maintain the treatment effect with reduced proteinuria and protection of kidney function over a total of 2 years of TARPEYO® treatment.

Connect with a study center

  • Advanced Renal Care Institute

    Mayagüez 4566385, 00680
    Puerto Rico

    Active - Recruiting

  • Univ of Alabama/Birmingham

    Birmingham, Alabama 35297
    United States

    Site Not Available

  • Univ of Alabama/Birmingham

    Birmingham 4049979, Alabama 4829764 35297
    United States

    Active - Recruiting

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    Glendale 5295985, Arizona 5551752 85306
    United States

    Active - Recruiting

  • The Medical Research Group, Inc.

    Fresno 5350937, California 5332921 93720
    United States

    Active - Recruiting

  • UCI Health-UCI Medical Center

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Loma Linda University

    San Bernardino 5391710, California 5332921 92408
    United States

    Active - Recruiting

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

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Stanford University

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

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

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Yale University Nephrology Clinical Trials Program

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University Nephrology Clinical Trials Program

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Florida Kidney Physicians

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Florida Kidney Physicians

    Boca Raton 4148411, Florida 4155751 33431
    United States

    Active - Recruiting

  • Central Florida Kidney Specialists

    Orlando 4167147, Florida 4155751 32819
    United States

    Active - Recruiting

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia 30904
    United States

    Site Not Available

  • Cobb Nephrology Hypertension Associates, PC

    Austell, Georgia 30106
    United States

    Site Not Available

  • Southeastern Clinical Research Institute, LLC

    Augusta 4180531, Georgia 4197000 30904
    United States

    Active - Recruiting

  • Cobb Nephrology Hypertension Associates, PC

    Austell 4180564, Georgia 4197000 30106
    United States

    Active - Recruiting

  • Georgia Nephrology

    Lawrenceville 4205196, Georgia 4197000 30046
    United States

    Active - Recruiting

  • University of Louisville

    Louisville 4299276, Kentucky 6254925 40208
    United States

    Active - Recruiting

  • Ochsner Health, New Orleans

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Health, New Orleans

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Active - Recruiting

  • University of Maryland Division of Nephrology

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

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

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis Park, Minnesota 63110
    United States

    Site Not Available

  • University of Minnesota Health Fairview

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

  • Washington University in St. Louis

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • Renal Medical Associates

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Renal Medical Associates

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Active - Recruiting

  • University of New Mexico

    Albuquerque 5454711, New Mexico 5481136 87106
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Chinatown Kidney Care, PLLC

    New York City, New York 10013
    United States

    Site Not Available

  • New York Nephrology Vasculitis and Glomerular Center

    Clifton Park 5112961, New York 5128638 12065
    United States

    Active - Recruiting

  • Chinatown Kidney Care, PLLC

    New York 5128581, New York 5128638 10013
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

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

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • University of Pennsylvania Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Dallas Renal Group

    Dallas, Texas 75230
    United States

    Site Not Available

  • MedResearch Inc

    El Paso, Texas 79902
    United States

    Site Not Available

  • The University of Texas Medical Branch UTMB

    Galveston, Texas 77555
    United States

    Site Not Available

  • Memorial Hermann Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • The Kidney Institute/Houston

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Dallas Nephrology Associates McKinney

    McKinney, Texas 75069
    United States

    Site Not Available

  • Permian Basin Kidney Center

    Odessa, Texas 79761
    United States

    Site Not Available

  • Dallas Renal Group

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • MedResearch Inc

    El Paso 5520993, Texas 4736286 79902
    United States

    Active - Recruiting

  • The University of Texas Medical Branch UTMB

    Galveston 4692883, Texas 4736286 77555
    United States

    Active - Recruiting

  • Memorial Hermann Houston

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • The Kidney Institute/Houston

    Houston 4699066, Texas 4736286 77090
    United States

    Active - Recruiting

  • Dallas Nephrology Associates McKinney

    McKinney 4710178, Texas 4736286 75069
    United States

    Active - Recruiting

  • Permian Basin Kidney Center

    Odessa 5527554, Texas 4736286 79761
    United States

    Active - Recruiting

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