An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

• Status: Completed
• Trial end date: 2014-06-01
• 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).

• 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

Inclusion Criteria:

1. Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial

2. eGFR ≥ 60 mL/min

3. Corrected Ca < 10.8 mg/dL

4. For female of child-bearing potential, a negative serum pregnancy test

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

6. Additional inclusion criteria apply

Exclusion Criteria:

1. Subject experienced a safety-related event in the KRN23-INT-001 study

2. Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study

3. Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study

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

5. Additional exclusion criteria apply