A Study of KRN23 in X-linked Hypophosphatemia

X-linked Hypophosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830674
• Other study ID #: KRN23-US-02
• Status: Completed
• Phase: Phase 1
• Start date: December 2008
• Est. completion date: May 2013

Study information

• Verified date: June 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypophosphatemic Rickets
• Hypophosphatemia
• X-linked Hypophosphatemia

Intervention

Drug:
• Placebo
single dose IV or SC administration
• KRN23
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

Locations

Country	Name	City	State
United States	Duke Clinical Research Unit	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	General Clinical Research Center, Indiana University School of Medicine	Indianapolis	Indiana
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	AEs, etc	Up to 7 weeks after dosing (maximally 11 weeks)
Secondary	Effect to pharmacodynamic parameter	Change in Serum Phosphate	Up to 7 weeks after dosing (maximally 11 weeks)

External Links

•   KRN23-INT-002 An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia