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

(NefXtend)

Sponsored by Calliditas Therapeutics AB

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 5, 2026

Phase

Clinical Trial

Sponsor

Calliditas Therapeutics AB

Enrollment Target

60

Start Date

Dec 2024

📊
1 of 60 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

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. Available retrospective data should include at least 1 assessment timepoint within 3 months prior to the first dose of TARPEYO® commercial treatment 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. Both samples of the same parameter must show either of the following:
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 wit

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

📋

Study Type

INTERVENTIONAL

👥

Target Enrollment

60 participants

Gender

ALL

🏢

Sponsor

Calliditas Therapeutics AB

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
RECRUITING

Glendale

Arizona

Location available
RECRUITING

Fresno

California

Location available
RECRUITING

Orange

California

Location available
RECRUITING

San Bernardino

California

Location available
RECRUITING

San Francisco

California

Location available
RECRUITING

Stanford

California

Location available
RECRUITING

Aurora

Colorado

Location available
RECRUITING

New Haven

Connecticut

Location available

📍 And 28 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Find More IgA Nephropathy Trials by City

Browse all iga nephropathy clinical trials in these cities — not just this study.

Looking for IgA Nephropathy Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

IgA Nephropathy Treatment Options in Birmingham, Alabama

If you're searching for IgA Nephropathy treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Glendale, Orange and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with IgA Nephropathy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for IgA Nephropathy?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for IgA Nephropathy

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This IgA Nephropathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06712407. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.