An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia

KRN23-INT-002

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).

2012-02-01

2013-09-01

2014-06-01

Completed

Early phase I

23

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}

2024-06-18