A Study of KRN23 in X-linked Hypophosphatemia

Phase 1

Completed

• Conditions: X-linked Hypophosphatemia
• Interventions: Drug: KRN23; Drug: Placebo

• Registration Number: NCT00830674
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2011-12
• Study Completion: 2013-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KRN23	KRN23	Single IV or SC administration on day 1
Placebo	Placebo	Single IV or SC administration on day 1

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	Up to 7 weeks after dosing (maximally 11 weeks)	AEs, etc

Secondary Outcome Measures

Name	Time	Method
Effect to pharmacodynamic parameter	Up to 7 weeks after dosing (maximally 11 weeks)	Change in Serum Phosphate

Trial Locations

Locations (4)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Duke Clinical Research Unit; 🇺🇸 Durham, North Carolina, United States

General Clinical Research Center, Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States