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

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

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

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: TARPEYO®

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Annette LeBlanc-Donahue; Phone Number: 844-442-0011; Email: medical.information@calliditas.com

Study Locations

• Puerto Rico
  • Mayagüez, Puerto Rico, 00680
    • Recruiting
    • Advanced Renal Care Institute
    • Contact: Principal Investigator
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35297
      • Recruiting
      • Univ of Alabama/Birmingham
      • Contact: Principal Investigator
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Recruiting
      • Arizona Kidney Disease & Hypertension Centers (AKDHC)
      • Contact: Principal Investigator
  • California
    • Fresno, California, United States, 93720
      • Recruiting
      • The Medical Research Group, Inc.
      • Contact: MacKenzie Moreno; Phone Number: 559-228-6600; Email: mmoreno@themedicalresearchgroup.com
      • Principal Investigator: Harpreet Dhindsa
    • Orange, California, United States, 92868
      • Recruiting
      • UCI Health-UCI Medical Center
      • Contact: Principal Investigator
    • San Bernardino, California, United States, 92408
      • Recruiting
      • Loma Linda University
      • Principal Investigator: Sayna Norouzi
      • Contact: Amber Jarvis; Phone Number: 909-558-5830; Email: ALJarvis@llu.edu
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice
      • Contact: PI
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Principal Investigator
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location
      • Contact: Principal Investigator
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University Nephrology Clinical Trials Program
      • Contact: Principal Investigator
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Recruiting
      • Florida Kidney Physicians
      • Contact: Principal Investigator
    • Orlando, Florida, United States, 32819
      • Recruiting
      • Central Florida Kidney Specialists
      • Contact: Principal Investigator
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Recruiting
      • Southeastern Clinical Research Institute, LLC
      • Contact: Principal Investigator
    • Austell, Georgia, United States, 30106
      • Recruiting
      • Cobb Nephrology Hypertension Associates, PC
      • Contact: Principal Investigator
    • Lawrenceville, Georgia, United States, 30046
      • Recruiting
      • Georgia Nephrology
      • Principal Investigator: James Tumlin
      • Contact: Julie Scoggin; Phone Number: 804-467-3158; Email: jscoggin@nephronet.com
  • Kentucky
    • Louisville, Kentucky, United States, 40208
      • Recruiting
      • University of Louisville
      • Contact: Jory Goff; Phone Number: 574-382-0102; Email: jory.goff@louisville.edu
      • Principal Investigator: Gunjan Garg
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Health, New Orleans
      • Contact: Principal Investigator
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Division of Nephrology
      • Contact: Hema Venkatesh; Phone Number: 410-706-4111; Email: HVenkatesh@som.umaryland.edu
      • Principal Investigator: Preeti Chandra
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine
      • Contact: Kemberlie Adolphe; Phone Number: 617- 414-7075; Email: Kemberlie.Adolphe@bmc.org
      • Principal Investigator: Ashish Upadhyay
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Health Fairview
      • Principal Investigator: Nattawat Klomjit
      • Contact: Ben Tang; Phone Number: 612-301-3382; Email: tang0266@umn.edu
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University in St. Louis
      • Contact: Principal Investigator
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Recruiting
      • University of New Mexico
      • Contact: Principal Investigator
    • Albuquerque, New Mexico, United States, 87109
      • Recruiting
      • Renal Medical Associates
      • Contact: Principal Investigator
  • New York
    • Clifton Park, New York, United States, 12065
      • Recruiting
      • New York Nephrology Vasculitis and Glomerular Center
      • Principal Investigator: Frank Cortazar
      • Contact: Tatiana Cordero; Phone Number: 13 518-434-2244; Email: tatiana.cordero@nyneph.com
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Principal Investigator
    • New York, New York, United States, 10013
      • Recruiting
      • Chinatown Kidney Care, PLLC
      • Contact: Principal Investigator
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Recruiting
      • North Carolina Nephrology, P.A
      • Contact: Mallory Phillips; Phone Number: 919-231-3966; Email: mphillips@ncnephrology.com
      • Principal Investigator: Michael Casey
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Principal Investigator
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic
      • Contact: Principal Investigator
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Philadelphia
      • Contact: Principal Investigator
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Dallas Renal Group
      • Contact: Principal Investigator
    • El Paso, Texas, United States, 79902
      • Recruiting
      • Medresearch Inc
      • Contact: Principal Investigator
    • Galveston, Texas, United States, 77555
      • Recruiting
      • The University of Texas Medical Branch UTMB
      • Contact: Principal Investigator
    • Houston, Texas, United States, 77054
      • Recruiting
      • Prolato Clinical Research Center
      • Contact: Principal Investigator
    • Houston, Texas, United States, 77054
      • Recruiting
      • Memorial Hermann Houston
      • Contact: Principal Investigator
    • Houston, Texas, United States, 77090
      • Recruiting
      • The Kidney Institute/Houston
      • Contact: Principal Investigator
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Dallas Nephrology Associates McKinney
      • Contact: Principal Investigator
    • Odessa, Texas, United States, 79761
      • Recruiting
      • Permian Basin Kidney Center
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline	The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline	The outcome is measured as UPCR (based on 24-hour urine collection) at 15 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 15 months in g/gram divided with UPCR at Baseline in g/gram.	15 months
Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)	Ratio of UPCR (based on 24-hour urine collection) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram	18 months
Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)	Ratio of UPCR (based on 24-hour urine collection) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram	27 months
Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline	The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 6 months following the first dose of TARPEYO® trial treatment compared to study baseline.	6 months
Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline	The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 15 months following the first dose of TARPEYO® trial treatment compared to study baseline.	15 months
Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)	The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 6 months following the first dose of TARPEYO® trial treatment compared to start of commercial treatment. Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment.	18 months
Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)	The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 15 months following the first dose of TARPEYO® trial treatment compared to start of commercial treatment. Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment.	27 months
Ratio of 24-hour urine proteinuria at 6 months compared to Baseline	The outcome is measured as proteinurea (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being proteinurea at 6 months in g/day divided with proteinurea at Baseline in g/day.	6 months
Ratio of 24-hour urine proteinuria at 15 months compared to Baseline	The outcome is measured as proteinurea (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being proteinurea at 15 months in g/day divided with proteinurea at Baseline in g/day.	15 months
Proportion of participants with microhematuria at 6 months	Number of participants with microhematuria at 6 months divided by total number of participants.	6 months
Proportion of participants with microhematuria at 15 months	Number of participants with microhematuria at 15 months divided by total number of participants.	15 months
To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment	SAEs and AEs will be evaluated and reported.	19 months

Collaborators and Investigators

• Sponsor: Calliditas Therapeutics AB
• Collaborators: Worldwide Clinical Trials
• Investigators: Study Director: Krassimir Mitchev, Calliditas Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ESRD; IgAN; Nefecon; TARPEYO®; urine protein-to-creatinine
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Glomerulonephritis; Nephritis; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Glomerulonephritis, IGA; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: Nef-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No