Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-02-23 @ 5:16 AM
Study NCT ID:
NCT02750618
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
Sponsor:
Kyowa Kirin, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old 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 the study are to:
* Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old
* Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH
* Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old
* Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: