StudyFinder
An open-label study 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
Status: Recruiting
This study is about finding out if the study drug, TARPEYO®, can be taken for a longer time (2 years) than the current recommended 9 months, to better help people with primary IgA nephropathy (IgAN).
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• diagnosed with biopsy-proven IgA nephropathy (IgAN)
• completed of 9 months of treatment of Tarpeyo 16mg twice a day (we start screening participants after 7 1/2 months of Tarpeyo treatment so we have enough time to complete all requirements before entering the study). Please contact the study team as early as possible.
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• treated with systemic immunosuppressants including glucocorticosteroids other than Tarpeyo during treatment of Tarpeyo
• current or planned dialysis
• undergone kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: TARPEYO®
Conditions:
Kidney, Prostate & Urinary
Keywords:
Berger's Disease, Clinics and Surgery Center (CSC), IgA Nephropathy, IgAN
Study Contact: Nattawat Klomjit - klomj001@umn.edu
Principal Investigator: Nattawat Klomjit
Phase: PHASE4
IRB Number: STUDY00024442
See this study on ClinicalTrials.gov