NCT06712407 Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
| NCT ID | NCT06712407 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Calliditas Therapeutics AB |
| Condition | IgA Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2026-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-12-17 with a primary completion date of 2026-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<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
Contact & Investigator
Krassimir Mitchev
STUDY DIRECTOR
Calliditas Therapeutics
Frequently Asked Questions
Who can join the NCT06712407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgA Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712407 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06712407 currently recruiting?
Yes, NCT06712407 is actively recruiting participants. Contact the research team at medical.information@calliditas.com for enrollment information.
Where is the NCT06712407 trial being conducted?
This trial is being conducted at Birmingham, United States, Glendale, United States, Fresno, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT06712407 clinical trial?
NCT06712407 is sponsored by Calliditas Therapeutics AB. The principal investigator is Krassimir Mitchev at Calliditas Therapeutics. The trial plans to enroll 60 participants.