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Clinical Trials in the USA / NCT06712407
Recruiting Phase 4

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

NCT06712407 · tracked via the Priya Life Science USA tracker
Sponsor
Calliditas Therapeutics AB
Phase
Phase 4
Started
2024-12-17
Last updated
2026-02-05

Condition(s) studied

IgA Nephropathy

Investigational drug(s) / intervention(s)

TARPEYO®

TARPEYO®: 6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Univ of Alabama/Birmingham Birmingham Alabama Recruiting
Arizona Kidney Disease & Hypertension Centers (AKDHC) Glendale Arizona Recruiting
The Medical Research Group, Inc. Fresno California Recruiting
UCI Health-UCI Medical Center Orange California Recruiting
Loma Linda University San Bernardino California Recruiting
UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice San Francisco California Recruiting
Stanford University Stanford California Recruiting
University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location Aurora Colorado Recruiting
Yale University Nephrology Clinical Trials Program New Haven Connecticut Recruiting
Florida Kidney Physicians Boca Raton Florida Recruiting
Central Florida Kidney Specialists Orlando Florida Recruiting
Southeastern Clinical Research Institute, LLC Augusta Georgia Recruiting
Cobb Nephrology Hypertension Associates, PC Austell Georgia Recruiting
Georgia Nephrology Lawrenceville Georgia Recruiting
University of Louisville Louisville Kentucky Recruiting
Ochsner Health, New Orleans New Orleans Louisiana Recruiting
University of Maryland Division of Nephrology Baltimore Maryland Recruiting
Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine Boston Massachusetts Recruiting
University of Minnesota Health Fairview Minneapolis Minnesota Recruiting
Washington University in St. Louis St Louis Missouri Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
Renal Medical Associates Albuquerque New Mexico Recruiting
New York Nephrology Vasculitis and Glomerular Center Clifton Park New York Recruiting
Chinatown Kidney Care, PLLC New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
North Carolina Nephrology, P.A Raleigh North Carolina Recruiting
Ohio State University Columbus Ohio Recruiting
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic Portland Oregon Recruiting
University of Pennsylvania Philadelphia Philadelphia Pennsylvania Recruiting
Dallas Renal Group Dallas Texas Recruiting
MedResearch Inc El Paso Texas Recruiting
The University of Texas Medical Branch UTMB Galveston Texas Recruiting
Memorial Hermann Houston Houston Texas Recruiting
Prolato Clinical Research Center Houston Texas Recruiting
The Kidney Institute/Houston Houston Texas Recruiting
Dallas Nephrology Associates McKinney McKinney Texas Recruiting
Permian Basin Kidney Center Odessa Texas Recruiting
Advanced Renal Care Institute Mayagüez Puerto Rico Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712407 on ClinicalTrials.gov ↗ ← All trials in the USA