A Study of KRN23 in X-linked Hypophosphatemia

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830674

Enrollment

Registered

2009-01-28

Start date

2008-12-31

Completion date

2013-05-31

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

X-linked Hypophosphatemia

Keywords

XLH

Brief summary

The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.

Interventions

DRUGPlacebo

single dose IV or SC administration

DRUGKRN23

Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 18 years or older 2. Clinical diagnosis of XLH 3. TmP/GFR is less than 2.0 mg/dL 4. GFR is 60 mL/min or above

Exclusion criteria

1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening 2. History of known immunodeficiency 3. Lactating females, female patients who are pregnant or planning to become pregnant during the study 4. Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing 5. Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing 6. Receipt of live (attenuated) vaccine within 3-months prior to screening 7. Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	Up to 7 weeks after dosing (maximally 11 weeks)	AEs, etc

Secondary

Measure	Time frame	Description
Effect to pharmacodynamic parameter	Up to 7 weeks after dosing (maximally 11 weeks)	Change in Serum Phosphate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026