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NCT06712407 · ClinicalTrials.gov record · last posted 2026-02-05

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

Study acronym: NefXtend
StatusRecruiting
PhasePhase 4
Started2024-12-17
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2026 (before its estimated May 29, 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2024-11-26; most recent amendment 2026-02-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-02-11
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06712407
Lead Sponsor Calliditas Therapeutics AB
Collaborators: Worldwide Clinical Trials
Conditions IgA Nephropathy
Enrollment 60 participants
Start Date 2024-12-17
Primary Completion 2026-05-29 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-02-05