AzTrials
AzTrials

IgA NephropathyPhase 4NefXtendNCT06712407

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

A Phase 4 study testing TARPEYO® in people with IgA Nephropathy, run by Calliditas Therapeutics AB at 38 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy
What is being tested?
TARPEYO®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
38 sitesin 2 countries
Study dates
17 Dec 2024to Feb 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed IgAN with biopsy verification
  • Female or male participants ≥18 years of age
  • Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy).
  • Presence of nephrotic syndrome (i.e., proteinuria >3.5 g per day and serum albumin <3.0 g/dL, with or without edema).
  • Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator.
  • On current or planned dialysis.
  • Undergone kidney transplant.
Show all 14Show fewer
  • Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
  • Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.
  • Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.
  • Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.
  • Participants unwilling or unable to meet the requirements of the protocol.
  • Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.
  • Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
  • Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States37 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Renal Medical Associates

    Albuquerque, New Mexico, 87109

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30904

  • University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location

    Aurora, Colorado, 80045

  • Cobb Nephrology Hypertension Associates, PC

    Austell, Georgia, 30106

  • University of Maryland Division of Nephrology

    Baltimore, Maryland, 21201

  • Univ of Alabama/Birmingham

    Birmingham, Alabama, 35297

  • Florida Kidney Physicians

    Boca Raton, Florida, 33431

  • Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine

    Boston, Massachusetts, 02118

  • New York Nephrology Vasculitis and Glomerular Center

    Clifton Park, New York, 12065

  • Ohio State University

    Columbus, Ohio, 43210

  • Dallas Renal Group

    Dallas, Texas, 75230

  • MedResearch Inc

    El Paso, Texas, 79902

  • The Medical Research Group, Inc.

    Fresno, California, 93720

  • The University of Texas Medical Branch UTMB

    Galveston, Texas, 77555

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    Glendale, Arizona, 85306

  • Memorial Hermann Houston

    Houston, Texas, 77054

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • The Kidney Institute/Houston

    Houston, Texas, 77090

  • Georgia Nephrology

    Lawrenceville, Georgia, 30046

  • University of Louisville

    Louisville, Kentucky, 40208

  • Dallas Nephrology Associates McKinney

    McKinney, Texas, 75069

  • University of Minnesota Health Fairview

    Minneapolis, Minnesota, 55455

  • Yale University Nephrology Clinical Trials Program

    New Haven, Connecticut, 06510

  • Ochsner Health, New Orleans

    New Orleans, Louisiana, 70121

  • Chinatown Kidney Care, PLLC

    New York, New York, 10013

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Permian Basin Kidney Center

    Odessa, Texas, 79761

  • UCI Health-UCI Medical Center

    Orange, California, 92868

  • Central Florida Kidney Specialists

    Orlando, Florida, 32819

  • University of Pennsylvania Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic

    Portland, Oregon, 97239

  • North Carolina Nephrology, P.A

    Raleigh, North Carolina, 27609

  • Loma Linda University

    San Bernardino, California, 92408

  • UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice

    San Francisco, California, 94143

  • Washington University in St. Louis

    St Louis, Missouri, 63130

  • Stanford University

    Stanford, California, 94305

Other trials in United States

Puerto Rico1 site

  • Advanced Renal Care Institute

    Mayagüez, 00680

Other trials in Puerto Rico

About this study

Official title: 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
Read the 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.

Conditions
IgA Nephropathy
Being tested
TARPEYO®
Keywords
TARPEYO®, IgAN, urine protein-to-creatinine, ESRD, Nefecon
Medical subject headings
Glomerulonephritis, IGA, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TARPEYO®Drug

    Also called delayed-release budesonide capsules

    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.

Study groups in NCT06712407
Study groupRoleWhat they receive
16 mg QD then 8 mg QDExperimental6-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.
Receives: Drug: TARPEYO®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (12)

  1. 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.

    Measured: 15 months

  2. 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

    Measured: 18 months

  3. 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

    Measured: 27 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 15 months

  6. 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.

    Measured: 18 months

  7. 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.

    Measured: 27 months

  8. 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.

    Measured: 6 months

  9. 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.

    Measured: 15 months

  10. Proportion of participants with microhematuria at 6 months

    Number of participants with microhematuria at 6 months divided by total number of participants.

    Measured: 6 months

  11. Proportion of participants with microhematuria at 15 months

    Number of participants with microhematuria at 15 months divided by total number of participants.

    Measured: 15 months

  12. To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment

    SAEs and AEs will be evaluated and reported.

    Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start17 Dec 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712407
Sponsor's protocol ID
Nef-403
Acronym
NefXtend
Status last verified
Sep 2026
First submitted
20 Nov 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TARPEYO® in people with IgA Nephropathy, run by Calliditas Therapeutics AB at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in