Phase 2
Completed N=23
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
Source: ClinicalTrials.gov NCT01571596 ↗Enrolled (actual)
23
Serious AEs
13.0%
Results posted
Feb 2021
Primary outcomePrimary: Safety and Efficacy of Repeated SC Injections of KRN23. — 21; 1; 1; 13 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Efficacy of Repeated SC Injections of KRN23. |
21; 1; 1; 13; 1; 0 | — |
| SECONDARY Evaluation of Effect of Repeated SC Injections of KRN23 |
1.85; 1.88; 2.86; 2.87; 2.48; 2.25 | — |
Eligibility Criteria
Inclusion Criteria
- Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
- eGFR ≥ 60 mL/min
- Corrected Ca < 10.8 mg/dL
- For female of child-bearing potential, a negative serum pregnancy test
- A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
- Additional inclusion criteria apply
Exclusion Criteria
- Subject experienced a safety-related event in the KRN23-INT-001 study
- Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
- Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
- Condition which could present a concern for either the subject's safety or difficulty with data interpretation
- Additional exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01571596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.