Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Recruiting · NCT06712407 · Interventional (participants receive a specific treatment) · Lead sponsor: Calliditas Therapeutics AB
View the official record on ClinicalTrials.gov →Interventions studied
TARPEYO®
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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.
- 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
- 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.
- On current or planned dialysis.
- Undergone kidney transplant.
- Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
- Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.
- Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.
- Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.
- Participants unwilling or unable to meet the requirements of the protocol.
- Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.
- Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
- Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4
Where it is running
38 locations listed across 20 US states.
- Univ of Alabama/Birmingham - Birmingham, Alabama, United States
- Arizona Kidney Disease & Hypertension Centers (AKDHC) - Glendale, Arizona, United States
- The Medical Research Group, Inc. - Fresno, California, United States
- UCI Health-UCI Medical Center - Orange, California, United States
- Loma Linda University - San Bernardino, California, United States
- UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice - San Francisco, California, United States
- Stanford University - Stanford, California, United States
- University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location - Aurora, Colorado, United States
- Yale University Nephrology Clinical Trials Program - New Haven, Connecticut, United States
- Florida Kidney Physicians - Boca Raton, Florida, United States
- Central Florida Kidney Specialists - Orlando, Florida, United States
- Southeastern Clinical Research Institute, LLC - Augusta, Georgia, United States
- Cobb Nephrology Hypertension Associates, PC - Austell, Georgia, United States
- Georgia Nephrology - Lawrenceville, Georgia, United States
- University of Louisville - Louisville, Kentucky, United States
- Ochsner Health, New Orleans - New Orleans, Louisiana, United States
- University of Maryland Division of Nephrology - Baltimore, Maryland, United States
- Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine - Boston, Massachusetts, United States
- University of Minnesota Health Fairview - Minneapolis, Minnesota, United States
- Washington University in St. Louis - St Louis, Missouri, United States
- University of New Mexico - Albuquerque, New Mexico, United States
- Renal Medical Associates - Albuquerque, New Mexico, United States
- New York Nephrology Vasculitis and Glomerular Center - Clifton Park, New York, United States
- Chinatown Kidney Care, PLLC - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- North Carolina Nephrology, P.A - Raleigh, North Carolina, United States
- Ohio State University - Columbus, Ohio, United States
- Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Portland, Oregon, United States
- University of Pennsylvania Philadelphia - Philadelphia, Pennsylvania, United States
- Dallas Renal Group - Dallas, Texas, United States
- MedResearch Inc - El Paso, Texas, United States
- The University of Texas Medical Branch UTMB - Galveston, Texas, United States
- Memorial Hermann Houston - Houston, Texas, United States
- Prolato Clinical Research Center - Houston, Texas, United States
- The Kidney Institute/Houston - Houston, Texas, United States
- Dallas Nephrology Associates McKinney - McKinney, Texas, United States
- Permian Basin Kidney Center - Odessa, Texas, United States
- Advanced Renal Care Institute - Mayagüez, Puerto Rico