Clinical Trial: An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
Brief Summary: The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Pharma, Inc.
Current Primary Outcome: Safety and efficacy of repeated SC injections of KRN23. [ Time Frame: 13.5 months,(50 visits) ]
Original Primary Outcome:
- Safety (number of AEs) after repeat-doses of KRN23 [ Time Frame: 12 months,(49 visits) ]
- Efficacy (serum phosphorus levels) after repeat-doses of KRN23 [ Time Frame: 12 months, (49 visits) ]
Current Secondary Outcome: Evaluation of effect of repeated SC injections of KRN23 [ Time Frame: 13.5 months, (50 visits) ]
Original Secondary Outcome:
- Changes from Baseline of trough KRN23 concentrations [ Time Frame: 12 months, 49 visits ]
- Changes in pharmacodynamic parameters (TmP/GFR, etc) by KRN23 dose levels from Baseline [ Time Frame: 12 months, 49 total visits ]
- Changes in bone biomarkers, by KRN23 dose levels from Baseline [ Time Frame: 12 months, 49 total visits ]
- Changes in bone mineral density and histomorphometric parameters by KRN23 dose levels compared to Placebo [ Time Frame: 12 months, 49 total visits ]
- Changes in Quality of Life measures by KRN23 dose levels from Baseline [ Time Frame: 12 months, 49 total visits ]
Information By: Kyowa Kirin Pharmaceutical Development, Inc.
Dates:
Date Received: February 23, 2012
Date Started: February 2012
Date Completion:
Last Updated: June 10, 2016
Last Verified: January 2015