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NCT06712407PHASE4Recruiting

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

Calliditas Therapeutics AB

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

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

Interventions

DRUG

TARPEYO®

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Conditions

IgA Nephropathy

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