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

Launched by CALLIDITAS THERAPEUTICS AB · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of continuing TARPEYO® treatment for adults with a kidney condition called primary IgA nephropathy (IgAN) beyond the initial 9 months of therapy. The researchers want to find out if taking TARPEYO® for a longer period can provide additional benefits for patients who have already been on the medication. Participants in the study will need to undergo various tests, including urine and blood samples, and will be involved for about 19 months.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of IgAN, and have completed 9 months of TARPEYO® treatment. They also need to have specific protein levels in their urine that indicate the severity of their condition. This trial is open to both men and women, and it excludes those with certain other health conditions or who are on specific treatments that might interfere with the study. If you choose to participate, you’ll be monitored closely to assess how well the treatment is working and to ensure your safety throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed IgAN with biopsy verification
• • 2. Female or male participants ≥18 years of age
• • 3. Completion of 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. Proteinuria at Screening based on 2 consecutive measurements (24-hour urine collection) after informed consent, separated by at least 1 week and calculated by the central laboratory.
• Both samples of the same parameter must show either of the following:
• • Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or
• • UPCR ≥0.3 g/gram in 2 consecutive measurements
• • 6. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy 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
• • 7. 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 and/or diabetes 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-month commercial 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