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NCT02750618 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
A Phase 2 study of X-linked Hypophosphatemia, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 3
- Study locations
NCT02750618: Completed Phase 2 study of X-linked Hypophosphatemia, sponsored by Kyowa Kirin.
NCT02750618 is a Phase 2 study of X-linked Hypophosphatemia that has completed, run by Kyowa Kirin. The registered enrollment target is 13 participants, below the 172-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02750618, a Phase 2 study of X-linked Hypophosphatemia, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objectives of the study are to: * Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old * Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH
Primary Outcome
The Generalized Estimation Equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.
Conditions Studied
Interventions
- BIOLOGICAL Burosumab
Study Locations (3)
Connecticut
- Yale University School of Medicine - New Haven
Indiana
- Indiana University School of Medicine - Indianapolis
Missouri
- Shriners Hospital for Children - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-05-05 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 2 |
What the finished NCT02750618 record still lists
NCT02750618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 172-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (92% lower).
The record links to 1 condition, with X-linked Hypophosphatemia appearing as the primary indexed condition, and to 1 intervention - of which Burosumab is the first listed.
NCT02750618 reports a single indexed study location in Connecticut, Indiana, Missouri.
Frequently Asked Questions
What is clinical trial NCT02750618 about?
NCT02750618 is a clinical study titled "Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)". The primary objectives of the study are to: * Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old * Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children betw...
What is the current status of trial NCT02750618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2016-05-05. Estimated completion is 2019-09-10.
What conditions does trial NCT02750618 study?
This clinical trial studies the following conditions: X-linked Hypophosphatemia.
What interventions are being tested in trial NCT02750618?
The interventions under investigation include: Burosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02750618?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02750618 being conducted?
This trial has 3 study locations across Connecticut, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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