Clinical Trial: A Study of KRN23 in X-linked Hypophosphatemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Kyowa Hakko Kirin Pharma, Inc.

Current Primary Outcome: Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]

AEs, etc


Original Primary Outcome: Change in Serum Phosphate [ Time Frame: Up to 4 weeks after dosing (maximally 6 weeks) ]

Current Secondary Outcome: Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]

Change in Serum Phosphate


Original Secondary Outcome:

Information By: Kyowa Kirin Pharmaceutical Development, Inc.

Dates:
Date Received: January 27, 2009
Date Started: December 2008
Date Completion:
Last Updated: October 18, 2013
Last Verified: October 2013