Home › Trials › NCT06712407

Extended treatment with TARPEYO® for IgA nephropathy patients

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

Phase 4 Interventional Calliditas Therapeutics AB · NCT06712407

This study is testing if extending treatment with TARPEYO® for another 15 months can help adults with IgA nephropathy reduce protein in their urine and protect their kidney function.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorCalliditas Therapeutics AB Industry-sponsored
Locations38 sites (Birmingham, Alabama and 37 other locations)
Trial IDNCT06712407 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of extending TARPEYO® treatment for an additional 15 months in adult patients with primary IgA nephropathy who have previously completed 9 months of treatment. Participants will undergo urine tests, blood sample collection, and physical examinations throughout the study, which lasts approximately 19 months. The study aims to determine if continued use of TARPEYO® can further reduce proteinuria and protect kidney function in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a biopsy-verified diagnosis of IgA nephropathy who have completed 9 months of TARPEYO® treatment.

Not a fit: Patients without a diagnosis of IgA nephropathy or those who have not completed the initial TARPEYO® treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved kidney function and reduced proteinuria for patients with IgA nephropathy.

How similar studies have performed: Previous studies have shown promise in using TARPEYO® for IgA nephropathy, making this approach a continuation of established treatment strategies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions IgA NephropathyTARPEYO®IgANurine protein-to-creatinineESRDNefecon
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.