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

Recruiting now · Phase 4

Conditions studied: IgA Nephropathy

In brief

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

Key facts

Study ID

NCT06712407

Run by

Calliditas Therapeutics AB

People needed

60

Starts

2024-12-17

Expected to finish

2027-11-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Univ of Alabama/Birmingham — Birmingham, Alabama, United States (enrolling)
• Arizona Kidney Disease & Hypertension Centers (AKDHC) — Glendale, Arizona, United States (enrolling)
• The Medical Research Group, Inc. — Fresno, California, United States (enrolling)
• UCI Health-UCI Medical Center — Orange, California, United States (enrolling)
• Loma Linda University — San Bernardino, California, United States (enrolling)
• UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice — San Francisco, California, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location — Aurora, Colorado, United States (enrolling)
• Yale University Nephrology Clinical Trials Program — New Haven, Connecticut, United States (enrolling)
• Florida Kidney Physicians — Boca Raton, Florida, United States (enrolling)
• Central Florida Kidney Specialists — Orlando, Florida, United States (enrolling)
• Southeastern Clinical Research Institute, LLC — Augusta, Georgia, United States (enrolling)
• Cobb Nephrology Hypertension Associates, PC — Austell, Georgia, United States (enrolling)
• Georgia Nephrology — Lawrenceville, Georgia, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Ochsner Health, New Orleans — New Orleans, Louisiana, United States (enrolling)
• University of Maryland Division of Nephrology — Baltimore, Maryland, United States (enrolling)
• Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine — Boston, Massachusetts, United States (enrolling)
• University of Minnesota Health Fairview — Minneapolis, Minnesota, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Renal Medical Associates — Albuquerque, New Mexico, United States (enrolling)
• New York Nephrology Vasculitis and Glomerular Center — Clifton Park, New York, United States (enrolling)
• Chinatown Kidney Care, PLLC — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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