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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080222550

Registered date:02/07/2014

A Phase 1 study of KRN23

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedX-linked Hypophosphatemic Rickets/Osteomalacia
Date of first enrollment02/07/2014
Target sample size15
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : KRN23 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Single SC administration on day 1

Outcome(s)

Primary OutcomeSafety Adverse events, laboratory tests
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients with XLH
Exclude criteria1. Have an active infection or chronic inflammatory disease 2. Have uncontrolled hypertension 3. Have uncontrolled diabetes mellitus 4. History of known immunodeficiency 5. Use of a pharmacologic vitamin D, or its metabolite or its analogs within 21 days prior to screening and after screening 6. Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening 7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

Related Information

Contact

Public contact
Name
Address clinical.info@kyowa-kirin.co.jp
Telephone
E-mail
Affiliation Kyowa Hakko Kirin Co., Ltd.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation