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NCT06712407 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of IgA Nephropathy, sponsored by Calliditas Therapeutics AB.

Recruiting
Registry status
Phase 4
Development phase
60
Enrollment target
20
Study locations

NCT06712407 is a Phase 4 study of IgA Nephropathy that is actively recruiting participants, run by Calliditas Therapeutics AB. The registered enrollment target is 60 participants, below the 161-participant average among 10 other IgA Nephropathy trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06712407, a Phase 4 study of IgA Nephropathy, is actively recruiting participants, sponsored by Calliditas Therapeutics AB.

RECRUITING
Registry status
Phase 4
Development phase
60 participants
Enrollment target
20
Study locations

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

IgA Nephropathy

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

5 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, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 161-participant average among 10 other IgA Nephropathy trials with a reported enrollment target (63% lower). The listed sponsor is Calliditas Therapeutics AB, which has 5 total studies on file at ClinicalTrials.gov.

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.

NCT06712407 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Florida.

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.

What interventions are being tested in trial NCT06712407?

The interventions under investigation include: TARPEYO® (DRUG).

Who is sponsoring clinical trial NCT06712407?

This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.