A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Pharma, Inc.
• Collaborators: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

Main Inclusion Criteria:

1. 18 years or older

2. Clinical diagnosis of XLH

3. TmP/GFR < 2.0 mg/dL

4. GFR ≥60 mL/min

5. Corrected Ca <10.8 mg/dL

6. A willingness to utilize adequate contraception and not become pregnant[or to have their partner(s) become pregnant] during the study

7. Additional inclusion criteria apply

Main Exclusion Criteria:

1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening

2. History of known immunodeficiency

3. Pregnant or lactating females subjects or female planning to be become pregnant during the study

4. Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study

5. Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing

6. Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing

7. Condition which could present a concern for either the subject's safety or difficulty with data interpretation

8. Additional exclusion criteria apply