drugset / Trial / NCT06712407

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

NCT06712407 ↗

Phase 4 Active not recruiting 60 enrolled Calliditas Therapeutics AB Worldwide Clinical Trials · collab
NaSequentialOpen-labelTreatment

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

Timeline

Start
2024-12-17
Primary completion
2027-03
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 8 mg —