RECRUITING

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

Conditions

IgA Nephropathy TARPEYO®IgAN urine protein-to-creatinine ESRD Nefecon

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-12-17

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06712407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosed IgAN with biopsy verification 2. Female or male participants ≥18 years of age 3. Completion of 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. 5. Proteinuria at Screening based on 2 consecutive measurements (24-hour urine collection) after informed consent, separated by at least 1 week and calculated by the central laboratory. * Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or * UPCR ≥0.3 g/gram in 2 consecutive measurements 6. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy 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 7. 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	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 and/or diabetes 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-month commercial 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

Inclusion Criteria

Exclusion Criteria

1. Diagnosed IgAN with biopsy verification
2. Female or male participants ≥18 years of age
3. Completion of 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.
5. Proteinuria at Screening based on 2 consecutive measurements (24-hour urine collection) after informed consent, separated by at least 1 week and calculated by the central laboratory.
* Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or
* UPCR ≥0.3 g/gram in 2 consecutive measurements
6. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy 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
7. 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

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 and/or diabetes 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-month commercial 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

Contacts and Locations

Study Contact

Kristin Önnestam

CONTACT

+46737456451

kristin.onnestam@calliditas.com

Principal Investigator

Kristin Önnestam

STUDY_DIRECTOR

Calliditas Therapeutics

Study Locations (Sites)

Dallas Renal Group

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: Calliditas Therapeutics AB

Kristin Önnestam, STUDY_DIRECTOR, Calliditas Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-17

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-12-17

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

TARPEYO®
IgAN
urine protein-to-creatinine
ESRD
Nefecon

Additional Relevant MeSH Terms

IgA Nephropathy