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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: Recruiting Phase 4 study of IgA Nephropathy, sponsored by Calliditas Therapeutics AB.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram.
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2027-11 |
| Phase | Phase 4 |
What NCT06712407 shows while recruiting
NCT06712407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 161-participant average among 10 other IgA Nephropathy trials with a reported enrollment target (63% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for IgA Nephropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06712407's enrollment target sits among peer trials
60 8th of 10 higher than 3 of 10 other IgA Nephropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other IgA Nephropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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