Extended TARPEYO® Treatment for IgA Nephropathy

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

Recruiting Phase 4 Interventional 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.

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About This Trial
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…
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…
Contacts

Annette LeBlanc-Donahue

844-442-0011

medical.information@calliditas.com

CONTACT