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Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

NCT02526160 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-06-18

Study results available
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Summary

The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.

Conditions

  • X-linked Hypophosphatemia

Interventions

BIOLOGICAL

burosumab

solution for SC injection

OTHER

Placebo

saline solution for SC injection

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Ultragenyx Pharmaceutical Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-22
Primary Completion
2016-12-22
Completion
2018-12-06

Countries

  • United States
  • France
  • Ireland
  • Italy
  • Japan
  • South Korea
  • United Kingdom

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 NCT02526160 on ClinicalTrials.gov