Clinical Trial: A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study 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). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Pharma, Inc.
Current Primary Outcome: Safety and Efficacy of repeated SC injections of KRN23 [ Time Frame: On-Treatment: 6.5 months, 27 total visits ]
Original Primary Outcome: Evaluate safety (number of AEs) and efficacy (serum Phosphorus levels), etc of repeat-doses of KRN23 [ Time Frame: On-Treatment: 4 months, 25 total visits ]
Current Secondary Outcome: Evaluation of effect of repeated SC injections of KRN23 [ Time Frame: On-Treatment: 6.5 months, 27 total visits ]
Original Secondary Outcome:
- Evaluate changes in phamacokinetic parameters by KRN23 dose levels [ Time Frame: On-Treatment: 4 months, 25 total visits ]
- Evaluate changes in pharmacodynamic parameters (TmP/GFR, etc) by KRN23 dose levels [ Time Frame: On-Treatment: 4 months, 25 total visits ]
- Evaluate changes in bone biomarkers, bone mineral density and histomorphometric measurements by KRN23 dose levels [ Time Frame: On-Treatment: 4 months, 25 total visits ]
- Evaluate changes in immunogenicity by KRN23 dose levels [ Time Frame: On-Treatment: 4 months, 25 total visits ]
- Evaluate changes in quality of life measures by KRN23 dose levels [ Time Frame: On-Treatment: 4 months, 25 total visits ]
Information By: Kyowa Kirin Pharmaceutical Development, Inc.
Dates:
Date Received: April 15, 2011
Date Started: April 2011
Date Completion:
Last Updated: June 10, 2016
Last Verified: January 2015