🏛️ Verified NIH Record • Updated 2026-02-03

Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy (NCT06712407)

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

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Calliditas Therapeutics AB

🩺 Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Univ of Alabama/Birmingham — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • Univ of Alabama/Birmingham — Birmingham, Alabama
  • Arizona Kidney Disease & Hypertension Centers (AKDHC) — Glendale, Arizona
  • The Medical Research Group, Inc. — Fresno, California
  • UCI Health-UCI Medical Center — Orange, California
  • Loma Linda University — San Bernardino, California
  • UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice — San Francisco, California
  • Stanford University — Stanford, California
  • University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location — Aurora, Colorado
  • Yale University Nephrology Clinical Trials Program — New Haven, Connecticut
  • Florida Kidney Physicians — Boca Raton, Florida
  • Central Florida Kidney Specialists — Orlando, Florida
  • Southeastern Clinical Research Institute, LLC — Augusta, Georgia
  • Cobb Nephrology Hypertension Associates, PC — Austell, Georgia
  • Georgia Nephrology — Lawrenceville, Georgia
  • University of Louisville — Louisville, Kentucky
  • Ochsner Health, New Orleans — New Orleans, Louisiana
  • University of Maryland Division of Nephrology — Baltimore, Maryland
  • Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine — Boston, Massachusetts
  • University of Minnesota Health Fairview — Minneapolis, Minnesota
  • Washington University in St. Louis — St Louis, Missouri
  • University of New Mexico — Albuquerque, New Mexico
  • Renal Medical Associates — Albuquerque, New Mexico
  • New York Nephrology Vasculitis and Glomerular Center — Clifton Park, New York
  • Chinatown Kidney Care, PLLC — New York, New York
  • Icahn School of Medicine at Mount Sinai — New York, New York

📞 Contact the Study Coordinator

Phone: (844) 442-0011

Email: medical.information@calliditas.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All IgA Nephropathy clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗