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
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.
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.
Sequential
TARPEYO®
Drug6-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.
Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline
The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram.
Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline
The outcome is measured as UPCR (based on 24-hour urine collection) at 15 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 15 months in g/gram divided with UPCR at Baseline in g/gram.
Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)
Ratio of UPCR (based on 24-hour urine collection) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram
Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)
Ratio of UPCR (based on 24-hour urine collection) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram
Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline
The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 6 months following the first dose of TARPEYO® trial treatment compared to study baseline.
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Calliditas Therapeutics AB
Lead sponsor
Worldwide Clinical Trials
Collaborator
