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Active Not Recruiting
NCT06712407
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Conditions: IgA Nephropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Calliditas Therapeutics AB
Location: Univ of Alabama/Birmingham Birmingham Alabama
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
Eligibility 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 \
Source: ClinicalTrials.gov (NCT06712407). StuddyBuddy aggregates publicly available trial information.