CALLIDITAS NEF 403: Extension Study for IgAN Treatment

Written By Paulina Schuler

About

The CALLIDITAS NEF 403 study is a Phase IV clinical trial designed to evaluate the long-term safety and effectiveness of TARPEYO® (budesonide) in adults with primary IgA nephropathy (IgAN). This study follows patients who have completed 9 months of commercial TARPEYO® treatment, extending the treatment period to assess its continued impact in real-world settings.

Who Can Participate

You may qualify for the CALLIDITAS NEF 403 trial if you:

  • Are an adult with IgA nephropathy (IgAN).

  • Have completed 9 months of TARPEYO® treatment under commercial use.

  • Are on stable background therapy with a renin-angiotensin system (RAS) inhibitor.

  • Have proteinuria of at least 0.5 g/day or a UPCR of at least 0.3 g/gram.

Trial Requirements

Participants will:

  • Continue treatment with TARPEYO® for an additional 6 months at 16 mg/day, followed by 9 months at 8 mg/day.

  • Attend check-ins every 3 months for blood and urine tests, safety evaluations, and data collection.

This study is focused on monitoring and assessing the long-term impact of TARPEYO® treatment.

Compensation

Monetary compensation is available for eligible participants.

Technical Details

  • Study Type: Phase IV extension, open-label.

  • Study Sponsor: Calliditas Therapeutics.

  • Duration: 18 months total (6 months at 16 mg/day, 9 months at 8 mg/day, 3-month follow-up).

  • Primary Goal: Assess the long-term efficacy and safety of TARPEYO® in real-world use.

  • Participant Safety: Comprehensive monitoring and care are provided by a specialized team.

Join us in advancing treatments for IgAN and improving outcomes for patients worldwide. Click below to check your eligibility!

Paulina Schuler