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

Last updated: June 30, 2025
Sponsor: Calliditas Therapeutics AB
Overall Status: Active - Recruiting

Phase

4

Condition

Nephropathy

Kidney Disease

Nephritis

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

  • Univ of Alabama/Birmingham

    Birmingham, Alabama 35297
    United States

    Active - Recruiting

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Yale University Nephrology Clinical Trials Program

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Florida Kidney Physicians

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia 30904
    United States

    Active - Recruiting

  • Cobb Nephrology Hypertension Associates, PC

    Austell, Georgia 30106
    United States

    Active - Recruiting

  • Ochsner Health, New Orleans

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis Park, Minnesota 63110
    United States

    Active - Recruiting

  • Renal Medical Associates

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Chinatown Kidney Care, PLLC

    New York City, New York 10013
    United States

    Active - Recruiting

  • Dallas Renal Group

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • MedResearch Inc

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • The University of Texas Medical Branch UTMB

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • Memorial Hermann Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • The Kidney Institute/Houston

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Dallas Nephrology Associates McKinney

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • Permian Basin Kidney Center

    Odessa, Texas 79761
    United States

    Active - Recruiting

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