Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-Linked Hypophosphatemia (XLH) Patients

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

KRN23 is an investigational drug being developed for the potential treatment of hypophosphatemia.

Men and women, age 18 and older, with a diagnosis of XLH may be eligible to participate.

Eligible participants must not have a history of allergic or anaphylactic reactions to any monoclonal antibody.

Participation requires willingness not to change diet and exercise regimen from one week prior to dosing of study drug to the end of the study.

Participation involves an out-patient screening period, five-night/six-day confinement stay for intravenous (IV) infusion of study drug or placebo and an out-patient observation and follow-up period.

For Duke contact study recruiter, Elise Pangborn at 919-681-9192.

For participation at Yale, contact study recruiter Becky Sullivan at 203-737-1656.

Last modified Jun 17, 2009

XLH is also known as X-Linked Hypophosphatemia (sometimes also spelled as hypophosphataemia), X-Linked Hypophosphatemic Rickets, Familial Hypophosphatemia, Vitamin D-Resistant Rickets (VDRR) Rickets and even Genetic Rickets. Its notable characteristics are bowed legs, short stature, poor teeth formation causing spontaneous dental abscesses, and low blood phosphorus levels.

© 2002-2009, The XLH Network Inc.
The authors of this web site are not medical professionals, and this information does not substitute for medical care. Information on these pages is based on biomedical research, published in peer-reviewed journals, and international research conferences. Additionally, in some cases anecdotal information is provided by subscribers of the F-HYPDRR group, a mailing list for The XLH Network Inc. A complete web-site bibliography is available. Please read our full disclaimer.