- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571596
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
January 29, 2021 updated by: Kyowa Hakko Kirin Pharma, Inc.
An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects 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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3G 1A6
- Shriners Hospital for Children - Canada
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California
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San Francisco, California, United States, 94143
- University of California San Francisco
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Clinical Research Center, Indiana University School of Medicine
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Clinical Research Unit
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
- eGFR ≥ 60 mL/min
- Corrected Ca < 10.8 mg/dL
- For female of child-bearing potential, a negative serum pregnancy test
- A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
- Additional inclusion criteria apply
Exclusion Criteria:
- Subject experienced a safety-related event in the KRN23-INT-001 study
- Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
- Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
- Condition which could present a concern for either the subject's safety or difficulty with data interpretation
- Additional exclusion criteria apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KRN23
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)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Efficacy of Repeated SC Injections of KRN23.
Time Frame: 13.5 months,(50 visits)
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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.
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13.5 months,(50 visits)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluation of Effect of Repeated SC Injections of KRN23
Time Frame: 13.5 months, (50 visits)
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Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus)
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13.5 months, (50 visits)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy
Time Frame: 13.5 months,(50 visits)
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Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.
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13.5 months,(50 visits)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 23, 2012
First Submitted That Met QC Criteria
April 3, 2012
First Posted (Estimate)
April 5, 2012
Study Record Updates
Last Update Posted (Actual)
February 17, 2021
Last Update Submitted That Met QC Criteria
January 29, 2021
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Nutrition Disorders
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Metabolism, Inborn Errors
- Bone Diseases, Metabolic
- Renal Tubular Transport, Inborn Errors
- Calcium Metabolism Disorders
- Metal Metabolism, Inborn Errors
- Phosphorus Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Rickets, Hypophosphatemic
- Hypophosphatemia, Familial
- Familial Hypophosphatemic Rickets
- Hypophosphatemia
Other Study ID Numbers
- KRN23-INT-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on X-linked Hypophosphatemia
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Kyowa Kirin Co., Ltd.Active, not recruiting
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Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-Linked HypophosphatemiaUnited States
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Kyowa Kirin Co., Ltd.Active, not recruitingX-linked Hypophosphatemia (XLH)China
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Kyowa Kirin Pharmaceutical Development LtdActive, not recruitingX-Linked HypophosphatemiaSpain, Italy, United Kingdom, France, Belgium, Denmark, Germany, Hungary, Portugal, Norway, Switzerland, Israel, Netherlands, Czechia, Bulgaria, Sweden, Slovenia, Ireland, Latvia, Slovakia
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Yale UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedHypophosphatemic Rickets, X Linked DominantUnited States
-
Kyowa Kirin Pharmaceutical Development LtdRecruitingX-Linked HypophosphatemiaFrance, Netherlands, United Kingdom
-
Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-Linked HypophosphatemiaKorea, Republic of, Canada, United States, Australia, Japan, United Kingdom, Sweden
-
Kyowa Kirin, Inc.CompletedX-Linked HypophosphatemiaUnited States
-
Kyowa Kirin Co., Ltd.Active, not recruitingX-linked Hypophosphatemia (XLH)China
-
Wuerzburg University HospitalKyowa Kirin, Inc.Active, not recruiting
Clinical Trials on KRN23
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Kyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.CompletedX-linked HypophosphatemiaUnited States, Canada
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Kyowa Hakko Kirin Pharma, Inc.Completed
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Kyowa Kirin Co., Ltd.CompletedX-linked Hypophosphatemic Rickets/OsteomalaciaJapan
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Kyowa Kirin Co., Ltd.CompletedTumor-Induced Osteomalacia or Epidermal Nevus SyndromeJapan, Korea, Republic of
-
Kyowa Kirin Co., Ltd.CompletedA Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaXLHJapan, Korea, Republic of
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Kyowa Kirin Co., Ltd.CompletedX-linked Hypophosphatemic Rickets/OsteomalaciaJapan, Korea, Republic of
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Ultragenyx Pharmaceutical IncKyowa Kirin Co., Ltd.AvailableX-linked Hypophosphatemia | Tumor-Induced Osteomalacia
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Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-Linked HypophosphatemiaUnited States
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Kyowa Kirin Pharmaceutical Development LtdCompletedX-linked HypophosphatemiaUnited Kingdom, France, Ireland, Italy
-
Kyowa Kirin, Inc.Kyowa Kirin Co., Ltd.CompletedX-linked HypophosphatemiaUnited States, Korea, Republic of, Japan, Ireland, United Kingdom, France, Italy