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Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

NCT02750618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-05-06

Study results available
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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

Conditions

  • X-Linked Hypophosphatemia

Interventions

BIOLOGICAL

Burosumab

solution for subcutaneous injection

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Ultragenyx Pharmaceutical Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-05
Primary Completion
2017-04-20
Completion
2019-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750618 on ClinicalTrials.gov