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RECRUITING

NCT06712407

PHASE4

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

Sponsor: Calliditas Therapeutics AB

View on ClinicalTrials.gov

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

Official title: An Open-label Study 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-17

Completion Date

2027-11

Last Updated

2026-02-05

Healthy Volunteers

Conditions

IgA Nephropathy

Interventions

DRUG

TARPEYO®

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.

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

Locations (38)

Univ of Alabama/Birmingham

Birmingham, Alabama, United States

Arizona Kidney Disease & Hypertension Centers (AKDHC)

Glendale, Arizona, United States

The Medical Research Group, Inc.

Fresno, California, United States

UCI Health-UCI Medical Center

Orange, California, United States

Loma Linda University

San Bernardino, California, United States

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

San Francisco, California, United States

Stanford University

Stanford, California, United States

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

Aurora, Colorado, United States

Yale University Nephrology Clinical Trials Program

New Haven, Connecticut, United States

Florida Kidney Physicians

Boca Raton, Florida, United States

Central Florida Kidney Specialists

Orlando, Florida, United States

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, United States

Cobb Nephrology Hypertension Associates, PC

Austell, Georgia, United States

Georgia Nephrology

Lawrenceville, Georgia, United States

University of Louisville

Louisville, Kentucky, United States

Ochsner Health, New Orleans

New Orleans, Louisiana, United States

University of Maryland Division of Nephrology

Baltimore, Maryland, United States

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

Boston, Massachusetts, United States

University of Minnesota Health Fairview

Minneapolis, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

Renal Medical Associates

Albuquerque, New Mexico, United States

New York Nephrology Vasculitis and Glomerular Center

Clifton Park, New York, United States

Chinatown Kidney Care, PLLC

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

North Carolina Nephrology, P.A

Raleigh, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

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

Portland, Oregon, United States

University of Pennsylvania Philadelphia

Philadelphia, Pennsylvania, United States

Dallas Renal Group

Dallas, Texas, United States

MedResearch Inc

El Paso, Texas, United States

The University of Texas Medical Branch UTMB

Galveston, Texas, United States

Memorial Hermann Houston

Houston, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

The Kidney Institute/Houston

Houston, Texas, United States

Dallas Nephrology Associates McKinney

McKinney, Texas, United States

Permian Basin Kidney Center

Odessa, Texas, United States

Advanced Renal Care Institute

Mayagüez, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (38)