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

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

CT.gov Identifier

NCT06712407

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

N/A

Study Contact Information

+46 8 411 3005

Recruiting

Study Details

Diseases

IgA nephropathy

Study Drug

Budesonide, Calliditas

Genes

N/A

Study Dates

Dec 2024 - May 2026

Sex

Female & Male

Age

18+ years

Inclusion and Exclusion Criteria

Inclusion Criteria:

Diagnosed IgAN with biopsy verificationFemale or male participants ≥18 years of ageCompletion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visitAccess 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.
Inclusion criteria: age ≥18 years old, biopsy-confirmed IgAN, ongoing, tolerated 9-month course of nefecon 16 mg/day treatment (with no substantial interruptions or dose reductions within 8 weeks prior to trial treatment, and no longer than 2 weeks at any point), proteinuria ≥0.5 g/day or UPCR ≥0.3 g/g based on two consecutive measurements, and stable, ongoing renin–angiotensin system inhibitor treatment for at least 8 weeks prior to baseline. Patients on a stable dose of sodium-glucose co-transporter-2 (SGLT2) inhibitors will be eligible.

Exclusion Criteria:

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
Exclusion criteria include systemic immunosuppressive medications (including systemic glucocorticoids) during the standard nefecon treatment period, other glomerular diseases, current or planned dialysis, previous kidney transplantation, and poorly controlled diabetes or hypertension.

Protocol Summary

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

Study Locations

To view all trial locations, click here

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