RecruitingPhase 4NCT06712407

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

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


Sponsor

Calliditas Therapeutics AB

Enrollment

60 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether continuing the kidney drug TARPEYO (budesonide) beyond the initial 9-month course provides additional benefit in adults with IgA nephropathy, a disease where the immune system damages the kidneys. **You may be eligible if...** - You are 18 or older with a biopsy-confirmed diagnosis of IgA nephropathy - You have completed a full 9-month course of TARPEYO 16 mg once daily - You are on a stable dose of a blood pressure/kidney-protective medication (RAS inhibitor or sparsentan) for at least 8 weeks - Your urine protein and kidney function data from before and during treatment are available **You may NOT be eligible if...** - You have not completed the initial 9-month TARPEYO treatment - Your kidney-protective medications are not at a stable dose - You do not have retrospective lab data available from before starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTARPEYO®

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.


Locations(38)

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

View Full Details on ClinicalTrials.gov

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NCT06712407


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