NCT02312687

Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)

A Phase 2b, Open-Label, Long-Term Extension Study to Evaluate the Safety and Pharmacodynamics of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• X-Linked Hypophosphatemia

Interventions

Type	Name	Description
BIOLOGICAL	KRN23	solution for SC injection

Timeline

• Start date: 2015-01-30
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2014-12-09
• Last updated: 2024-05-06
• Results posted: 2019-12-16

Locations

5 sites across 1 country: United States