Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2019-01-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with hereditary hypophosphatemic rickets with HHRH
Hereditary hypophosphatemic rickets with hypercalciuria (HHRH)
phosphate
The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
Patients with X-linked Hypophosphatemia
Patients with X-linked hypophosphatemia
phosphate
The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
15 Patients with X-linked Hypophosphatemia
15 Patients with X-linked Hypophosphatemia that will receive phosphate treatment for 30 days.
phosphate
The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
15 Patients Hereditary hypophosphatemic rickets with HHRH
15 patients withHereditary hypophosphatemic rickets with hypercalciuria (HHRH) that will receive phosphate treatment for 30 days.
phosphate
The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
Interventions
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phosphate
The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
Eligibility Criteria
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Inclusion Criteria
* Younger and older adults with XLH and HHRH with confirmed NPT2c mutations affecting both copies of the NPT2c gene (HHRH) or one copy of the PHEX gene (XLH)
* Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data
* Be willing and able to complete all aspects of the study
* Be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator).
Exclusion Criteria
* Subjects that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy),
* Subjects that are currently pregnant,
* Subjects that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject safety or difficulty with data interpretation.
* Subjects will be excluded from Aim 2, if they are unable to tolerate supplemental phosphate.
13 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Clemens Bergwitz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2000023461
Identifier Type: -
Identifier Source: org_study_id
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