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NCT02312687 · ClinicalTrials.gov registry record · Phase 2
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
A Phase 2 study, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02312687 is a Phase 2 study that has completed, run by Kyowa Kirin. The registered enrollment target is 20 participants.
The verdict
NCT02312687, a Phase 2 study, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objectives of this study are to: * Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH * Assess the proportion of subjects achieving serum phosphorus levels in the normal range (2.5-4.5 mg/dL) with long-term administration of KRN23 * Assess long-term pharmacodynamics (PD) of KRN23 as measured by changes in the following: serum intact parathyroid hormone (iPTH); serum and urinary phosphorus; ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate (TmP/GFR) and tubular reabsorption of phosphate (TRP); serum 1,25-dihydroxy vitamin D (1,25\[OH\]2D); serum fibroblast growth factor 23 (FGF23); bone biomarkers: serum alkaline phosphatase (ALP), bone-specific ALP (BALP), carboxy terminal crosslinked telopeptide of type I collagen (CTx), and procollagen type 1 N-terminal propeptide (P1NP) * Assess long-term immunogenicity of KRN23 as measured by presence of anti-KRN23 antibody (ADA)
Interventions
- BIOLOGICAL KRN23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-01-30 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02312687
The ClinicalTrials.gov registry entry for NCT02312687 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which KRN23 is the first listed.
NCT02312687 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02312687 about?
NCT02312687 is a clinical study titled "Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)". The primary objectives of this study are to: * Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH * Assess the proportion of subjects achieving serum phosphorus levels in the normal range (2.5-4.5 mg/dL) with long-term administration of KRN23 * Assess l...
What is the current status of trial NCT02312687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-01-30. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT02312687?
The interventions under investigation include: KRN23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02312687?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
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