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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
There are 2 treatment periods with the study drug: - TARPEYO® 16 mg (4 capsules) once a day for 6 months - TARPEYO® 8 mg (2 capsules) once a day for 9 months.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
16 mg QD then 8 mg QD 		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.
  • Drug: 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.
    Other names:
    • delayed-release budesonide capsules

Recruiting Locations

Univ of Alabama/Birmingham
Birmingham, Alabama 35297
Contact:
Principal Investigator

Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale, Arizona 85306
Contact:
Principal Investigator

The Medical Research Group, Inc.
Fresno, California 93720
Contact:
Mackenzie Moreno
559-228-6600
mmoreno@themedicalresearchgroup.com

UCI Health-UCI Medical Center
Orange, California 92868
Contact:
Principal Investigator

Loma Linda University
San Bernardino, California 92408
Contact:
Amber Jarvis
909-558-5830
ALJarvis@llu.edu

UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice
San Francisco, California 94143
Contact:
PI

Stanford University
Stanford, California 94305
Contact:
Principal Investigator

University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location
Aurora, Colorado 80045
Contact:
Principal Investigator

Yale University Nephrology Clinical Trials Program
New Haven, Connecticut 06510
Contact:
Principal Investigator

Florida Kidney Physicians
Boca Raton, Florida 33431
Contact:
Principal Investigator

Central Florida Kidney Specialists
Orlando, Florida 32819
Contact:
Principal Investigator

Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904
Contact:
Principal Investigator

Cobb Nephrology Hypertension Associates, PC
Austell, Georgia 30106
Contact:
Principal Investigator

Georgia Nephrology
Lawrenceville, Georgia 30046
Contact:
Julie Scoggin
804-467-3158
jscoggin@nephronet.com

University of Louisville
Louisville, Kentucky 40208
Contact:
Jory Goff
574-382-0102
jory.goff@louisville.edu

Ochsner Health, New Orleans
New Orleans, Louisiana 70121
Contact:
Principal Investigator

University of Maryland Division of Nephrology
Baltimore, Maryland 21201
Contact:
Hema Venkatesh
410-706-4111
HVenkatesh@som.umaryland.edu

Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts 02118
Contact:
Kemberlie Adolphe
617- 414-7075
Kemberlie.Adolphe@bmc.org

University of Minnesota Health Fairview
Minneapolis, Minnesota 55455
Contact:
Ben Tang
612-301-3382
tang0266@umn.edu

Washington University in St. Louis
St Louis, Missouri 63130
Contact:
Principal Investigator

University of New Mexico
Albuquerque, New Mexico 87106
Contact:
Principal Investigator

Renal Medical Associates
Albuquerque, New Mexico 87109
Contact:
Principal Investigator

New York Nephrology Vasculitis and Glomerular Center
Clifton Park, New York 12065
Contact:
Tatiana Cordero
518-434-2244
tatiana.cordero@nyneph.com

Chinatown Kidney Care, PLLC
New York, New York 10013
Contact:
Principal Investigator

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Principal Investigator

North Carolina Nephrology, P.A
Raleigh, North Carolina 27609
Contact:
Mallory Phillips
919-231-3966
mphillips@ncnephrology.com

Ohio State University
Columbus, Ohio 43210
Contact:
Principal Investigator

Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic
Portland, Oregon 97239
Contact:
Principal Investigator

University of Pennsylvania Philadelphia
Philadelphia, Pennsylvania 19104
Contact:
Principal Investigator

Dallas Renal Group
Dallas, Texas 75230
Contact:
Principal Investigator

MedResearch Inc
El Paso, Texas 79902
Contact:
Principal Investigator

The University of Texas Medical Branch UTMB
Galveston, Texas 77555
Contact:
Principal Investigator

Memorial Hermann Houston
Houston, Texas 77054
Contact:
Principal Investigator

Prolato Clinical Research Center
Houston, Texas 77054
Contact:
Principal Investigator

The Kidney Institute/Houston
Houston, Texas 77090
Contact:
Principal Investigator

Dallas Nephrology Associates McKinney
McKinney, Texas 75069
Contact:
Principal Investigator

Permian Basin Kidney Center
Odessa, Texas 79761
Contact:
Principal Investigator

Advanced Renal Care Institute
Mayagüez, Puerto Rico 00680
Contact:
Principal Investigator

More Details

NCT ID
NCT06712407
Status
Recruiting
Sponsor
Calliditas Therapeutics AB

Study Contact

Annette LeBlanc-Donahue
844-442-0011
medical.information@calliditas.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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