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) ]

Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.


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) ]

Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters including serum phosphorus,sex hormone, bone biomarkers, quality of life assessments and population pharmacokinetics of KRN23 dose levels from cumulative dosing.


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