Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Recruiting
Phase 4Interventional Study
IgA Nephropathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Calliditas Therapeutics AB · Industry
Who this trial is looking for
This trial is looking for adults with IgA nephropathy who have completed 9 months of TARPEYO® treatment. Participants will take part for about 19 months and undergo urine tests, blood samples, and physical exams.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with IgA nephropathy verified by biopsy.
I am at least 18 years old.
I have completed 9 months of TARPEYO® 16 mg treatment.
I have access to local lab data on my kidney function.
I have been on a stable dose of RAS inhibitor or sparsentan for at least 8 weeks.
If I take SGLT2 inhibitor, my dose has been stable for at least 8 weeks.
You may not be able to join if
I have used systemic immunosuppressive medications during TARPEYO® treatment.
I have another kidney disease.
I have nephrotic syndrome.
I am on dialysis or plan to start.
I have had a kidney transplant.
I have uncontrolled diabetes or high blood pressure.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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?
Participa…
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
Trial Locations
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Eligibility Criteria
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 creatini…
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
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