A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
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|ClinicalTrials.gov Identifier: NCT01340482|
Recruitment Status : Completed
First Posted : April 22, 2011
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 :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||October 2013|
Escalating doses of KRN23 (0.05, 0.10, 0.30 and 0.60 mg/kg) will be administered SC every 28 days (up to 4 doses)
Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.
- Safety and Efficacy of repeated SC injections of KRN23 [ Time Frame: On-Treatment: 6.5 months, 27 total 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: On-Treatment: 6.5 months, 27 total 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: On-Treatment: 6.5 months, 27 total visits ]Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density and bone quality.
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): NCT01340482
|United States, California|
|University of California, San Francisco Medical Center|
|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, 46202-5250|
|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.|