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

Study acronym: NefXtend
StatusActive, Not Recruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later May 29, 2026 → Mar 2027
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Record History

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  1. Primary completion pushed from May 29, 2026 to Mar 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Nov 2027 to Feb 2028
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 9 of 12 entries
    • Site details revised at 38 of 38 sites
  2. Study sites: 37 to 38
    • Eligibility criteria shortened, about 53 words
    • Study description expanded, about 2 words
    v10
  3. Study sites: 29 to 37v9
  4. Re-verified, no change to tracked fieldsv8
  5. Study sites: 19 to 29v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 12 to 19v6
  2. Study sites: 11 to 12v5
  3. Study sites: 9 to 11v4
  4. Study sites: 1 to 9v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 15, 2024 to Dec 17, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06712407
Lead Sponsor Calliditas Therapeutics AB
Collaborators: Worldwide Clinical Trials
Conditions
(from sponsor)		 IgA Nephropathy
Related terms Glomerulonephritis, IGA, Kidney Failure, Chronic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov