Ignite Creation Date:
2024-05-06 @ 3:31 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02312687
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2014-12-03
Brief Title:
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia XLH
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03775187
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief 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 25-45 mgdL 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 TmPGFR and tubular reabsorption of phosphate TRP serum 125-dihydroxy vitamin D 125OH2D 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
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 25-45 mgdL 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 TmPGFR and tubular reabsorption of phosphate TRP serum 125-dihydroxy vitamin D 125OH2D 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None