An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
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, bone quality and histomorphometric parameters.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia|
- Safety and efficacy of repeated SC injections of KRN23. [ Time Frame: 13.5 months,(50 visits) ] [ Designated as safety issue: Yes ]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.
- Evaluation of effect of repeated SC injections of KRN23 [ Time Frame: 13.5 months, (50 visits) ] [ Designated as safety issue: No ]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.
- Evaluation of effect of repeated SC injections of KRN23 in Bone Substudy [ Time Frame: 13.5 months,(50 visits) ] [ Designated as safety issue: No ]Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Open-Label KRN23; Single-blind KRN23 vs Placebo||
Drug: Biological KRN23
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 4 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Indiana|
|Clinical Research Center, Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|Duke Clinical Research Unit|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Shriners Hospital for Children - Canada|
|Montreal, Quebec, Canada, H3G 1A6|
|Study Director:||Amy Zhang, PhD||Kyowa Hakko Kirin Pharma|