An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01571596|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : June 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|X-linked Hypophosphatemia||Drug: KRN23||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||June 2014|
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
- 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.
- 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.
- Evaluation of effect of repeated SC injections of KRN23 in Bone Substudy [ Time Frame: 13.5 months,(50 visits) ]Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571596
|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, Inc.|