- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237288
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
September 30, 2013 updated by: Zeria Pharmaceutical
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 3
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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-
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Chiba, Japan
- Chiba Children's Hospital
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Kanagawa, Japan
- Kanagawa Children's Medical Center
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Osaka, Japan
- Osaka University Hospital
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Tokyo, Japan
- Tokyo Metropolitan Children's Medical Center
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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
1 year to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.
Exclusion Criteria:
- A hyperparathyroidism
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: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Z-521
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum ALP level
Time Frame: 6 month
|
6 month
|
Serum phosphate level
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Keiichi Ozono, M.D., Ph.D., Osaka University Hospital
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.
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
September 1, 2010
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
November 7, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (ESTIMATE)
November 9, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 1, 2013
Last Update Submitted That Met QC Criteria
September 30, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
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
- Vitamin D Deficiency
- Hypophosphatemia, Familial
- Hypophosphatemia
- Rickets
- Familial Hypophosphatemic Rickets
- Rickets, Hypophosphatemic
Other Study ID Numbers
- 10010301
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 Primary Hypophosphatemic Rickets
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Bicetre HospitalCompletedX Linked Hypophosphatemic Rickets
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Yale UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedHypophosphatemic Rickets, X Linked DominantUnited States
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Kyowa Kirin Co., Ltd.CompletedX-linked Hypophosphatemic Rickets/OsteomalaciaJapan
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Kyowa Kirin Co., Ltd.CompletedX-linked Hypophosphatemic Rickets/OsteomalaciaJapan, Korea, Republic of
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Hospices Civils de LyonNot yet recruitingX-Linked Hypophosphatemic Rickets
-
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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Indiana UniversityCompletedAutosomal Dominant Hypophosphatemic RicketsUnited States
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Inozyme PharmaEngage Health Inc.; GACI GlobalCompletedGeneralized Arterial Calcification in Infancy | Autosomal Recessive Hypophosphatemic Rickets Type 2United States
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Children's Mercy Hospital Kansas CityCompletedHypophosphatemic Rickets, X-Linked DominantUnited States
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Yale UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedHyperparathyroidism | Hypophosphatemia, FamilialUnited States
Clinical Trials on Z-521
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Anza Therapeutics, Inc.TerminatedChronic Hepatitis CUnited States
-
University of NottinghamUniversity Hospitals of Derby and Burton NHS Foundation TrustCompletedNeonatal DiseaseUnited Kingdom
-
University of California, DavisCompleted
-
Jürgen WeissUnknown
-
University of OxfordUnknownEbola Virus DiseaseUnited Kingdom
-
Zeria PharmaceuticalCompletedAdvanced Hepatocellular CarcinomaJapan
-
Everfront Biotech Co., Ltd.Active, not recruitingAmyotrophic Lateral SclerosisTaiwan
-
University of WashingtonCompletedHypertrophic Scarring After Burn InjuryUnited States
-
Zeria PharmaceuticalTerminated
-
Tarsus UniversityNot yet recruiting