JRCT ID: jRCT2080222550
Registered date:02/07/2014
A Phase 1 study of KRN23
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | X-linked Hypophosphatemic Rickets/Osteomalacia |
Date of first enrollment | 02/07/2014 |
Target sample size | 15 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Safety Adverse events, laboratory tests |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Patients with XLH |
Exclude criteria | 1. 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
Primary Sponsor | Kyowa Hakko Kirin Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-142601 |
Contact
Public contact | |
Name | |
Address | clinical.info@kyowa-kirin.co.jp |
Telephone | |
Affiliation | Kyowa Hakko Kirin Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |