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

NCT06712407 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Nef-403
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 38

Brief 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

Conditions

IgA Nephropathy

Keywords

TARPEYO®; IgAN; urine protein-to-creatinine; ESRD; Nefecon

Outcome Measures

Primary Outcomes (1)

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline

  The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram.

  6 months

Secondary Outcomes (12)

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline

  15 months

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)

  18 months

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)

  27 months

• Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline

  6 months

• Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline

  15 months

Study Arms (1)

16 mg QD then 8 mg QD

EXPERIMENTAL

6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Drug: TARPEYO®

Interventions

TARPEYO® DRUG

6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Also known as: delayed-release budesonide capsules

16 mg QD then 8 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed IgAN with biopsy verification
• Female or male participants ≥18 years of age
• Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy).
• Presence of nephrotic syndrome (i.e., proteinuria \>3.5 g per day and serum albumin \<3.0 g/dL, with or without edema).
• Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator.
• On current or planned dialysis.
• Undergone kidney transplant.
• Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
• Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.
• Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.
• Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.
• Participants unwilling or unable to meet the requirements of the protocol.
• Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.
• Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
• Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4

Sponsors & Collaborators

• Calliditas Therapeutics AB: lead
• Worldwide Clinical Trials: collaborator

Study Sites (38)

Univ of Alabama/Birmingham

Birmingham, Alabama, 35297, United States

RECRUITING

Arizona Kidney Disease & Hypertension Centers (AKDHC)

Glendale, Arizona, 85306, United States

RECRUITING

The Medical Research Group, Inc.

Fresno, California, 93720, United States

RECRUITING

UCI Health-UCI Medical Center

Orange, California, 92868, United States

RECRUITING

Loma Linda University

San Bernardino, California, 92408, United States

RECRUITING

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

San Francisco, California, 94143, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

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

Aurora, Colorado, 80045, United States

RECRUITING

Yale University Nephrology Clinical Trials Program

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Kidney Physicians

Boca Raton, Florida, 33431, United States

RECRUITING

Central Florida Kidney Specialists

Orlando, Florida, 32819, United States

RECRUITING

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States

RECRUITING

Cobb Nephrology Hypertension Associates, PC

Austell, Georgia, 30106, United States

RECRUITING

Georgia Nephrology

Lawrenceville, Georgia, 30046, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40208, United States

RECRUITING

Ochsner Health, New Orleans

New Orleans, Louisiana, 70121, United States

RECRUITING

University of Maryland Division of Nephrology

Baltimore, Maryland, 21201, United States

RECRUITING

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

Boston, Massachusetts, 02118, United States

RECRUITING

University of Minnesota Health Fairview

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87106, United States

RECRUITING

Renal Medical Associates

Albuquerque, New Mexico, 87109, United States

RECRUITING

New York Nephrology Vasculitis and Glomerular Center

Clifton Park, New York, 12065, United States

RECRUITING

Chinatown Kidney Care, PLLC

New York, New York, 10013, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

North Carolina Nephrology, P.A

Raleigh, North Carolina, 27609, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

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

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Dallas Renal Group

Dallas, Texas, 75230, United States

RECRUITING

MedResearch Inc

El Paso, Texas, 79902, United States

RECRUITING

The University of Texas Medical Branch UTMB

Galveston, Texas, 77555, United States

RECRUITING

Memorial Hermann Houston

Houston, Texas, 77054, United States

RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77054, United States

RECRUITING

The Kidney Institute/Houston

Houston, Texas, 77090, United States

RECRUITING

Dallas Nephrology Associates McKinney

McKinney, Texas, 75069, United States

RECRUITING

Permian Basin Kidney Center

Odessa, Texas, 79761, United States

RECRUITING

Advanced Renal Care Institute

Mayagüez, 00680, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Failure, Chronic

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Krassimir Mitchev

  Calliditas Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Annette LeBlanc-Donahue

CONTACT

844-442-0011; medical.information@calliditas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are 2 treatment periods with the study drug: * TARPEYO® 16 mg (4 capsules) once a day for 6 months * TARPEYO® 8 mg (2 capsules) once a day for 9 months.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 2, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (37)