Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Start Date
12/17/2024
Completion Date
11/1/2027
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
Detailed Description
This clinical trial will investigate the efficacy and safety of TARPEYO® treatment extended for an additional 15 months in adult IgAN participants who have completed their initial, single 9-month TARPEYO® 16 mg QD commercial treatment regimen. Participants with residual proteinuria will be eligible for enrollment. The Treatment Period will consist of a 6-month Treatment Period with TARPEYO® 16 mg QD, followed by a 9-month Treatment Period with TARPEYO® 8 mg QD. This will be followed by a 3-month Follow-up Period, which includes the first 2 weeks of Tapering Period with TARPEYO® 4 mg QD. The overall aim of the extended treatment is to improve and maintain the treatment effect with reduced proteinuria and protection of kidney function over a total of 2 years of TARPEYO® treatment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TARPEYO®
Conditions
Locations
Univ of Alabama/Birmingham
Birmingham, Alabama 35297
United States
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale, Arizona 85306
United States
The Medical Research Group, Inc.
Fresno, California 93720
United States
UCI Health-UCI Medical Center
Orange, California 92868
United States
Loma Linda University
San Bernardino, California 92408
United States
UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice
San Francisco, California 94143
United States
Stanford University
Stanford, California 94305
United States
University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location
Aurora, Colorado 80045
United States
Yale University Nephrology Clinical Trials Program
New Haven, Connecticut 06510
United States
Florida Kidney Physicians
Boca Raton, Florida 33431
United States
Central Florida Kidney Specialists
Orlando, Florida 32819
United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904
United States
Cobb Nephrology Hypertension Associates, PC
Austell, Georgia 30106
United States
Georgia Nephrology
Lawrenceville, Georgia 30046
United States
University of Louisville
Louisville, Kentucky 40208
United States
Ochsner Health, New Orleans
New Orleans, Louisiana 70121
United States
University of Maryland Division of Nephrology
Baltimore, Maryland 21201
United States
Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts 02118
United States
University of Minnesota Health Fairview
Minneapolis, Minnesota 55455
United States
Washington University in St. Louis
St Louis, Missouri 63130
United States
University of New Mexico
Albuquerque, New Mexico 87106
United States
Renal Medical Associates
Albuquerque, New Mexico 87109
United States
New York Nephrology Vasculitis and Glomerular Center
Clifton Park, New York 12065
United States
Chinatown Kidney Care, PLLC
New York, New York 10013
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
North Carolina Nephrology, P.A
Raleigh, North Carolina 27609
United States
Ohio State University
Columbus, Ohio 43210
United States
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic
Portland, Oregon 97239
United States
University of Pennsylvania Philadelphia
Philadelphia, Pennsylvania 19104
United States
Dallas Renal Group
Dallas, Texas 75230
United States
MedResearch Inc
El Paso, Texas 79902
United States
The University of Texas Medical Branch UTMB
Galveston, Texas 77555
United States
Memorial Hermann Houston
Houston, Texas 77054
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
The Kidney Institute/Houston
Houston, Texas 77090
United States
Dallas Nephrology Associates McKinney
McKinney, Texas 75069
United States
Permian Basin Kidney Center
Odessa, Texas 79761
United States
Advanced Renal Care Institute
Mayagüez, 00680
Puerto Rico