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RECRUITING Phase 4

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

NCT06712407 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG TARPEYO®

Study Locations (20)

California

  • The Medical Research Group, Inc. — Fresno
  • UCI Health-UCI Medical Center — Orange
  • Loma Linda University — San Bernardino
  • UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice — San Francisco
  • Stanford University — Stanford

Georgia

  • Southeastern Clinical Research Institute, LLC — Augusta
  • Cobb Nephrology Hypertension Associates, PC — Austell
  • Georgia Nephrology — Lawrenceville

Florida

  • Florida Kidney Physicians — Boca Raton
  • Central Florida Kidney Specialists — Orlando

Alabama

  • Univ of Alabama/Birmingham — Birmingham

Arizona

  • Arizona Kidney Disease & Hypertension Centers (AKDHC) — Glendale

Colorado

  • University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location — Aurora

Connecticut

  • Yale University Nephrology Clinical Trials Program — New Haven

Kentucky

  • University of Louisville — Louisville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-12-17
Est. Completion 2027-11
Phase Phase 4

Sponsor

Calliditas Therapeutics AB

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06712407

The ClinicalTrials.gov registry entry for NCT06712407 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calliditas Therapeutics AB, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with IgA Nephropathy appearing as the primary indexed condition, and to 1 intervention — of which TARPEYO® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06712407 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06712407 about?

NCT06712407 is a clinical study titled "Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy". 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 questi...

What is the current status of trial NCT06712407?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-12-17. Estimated completion is 2027-11.

What conditions does trial NCT06712407 study?

This clinical trial studies the following conditions: IgA Nephropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06712407?

The interventions under investigation include: TARPEYO® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06712407?

This trial is sponsored by Calliditas Therapeutics AB, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06712407 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial