Phase 2 N=23 Treatment

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

X-linked Hypophosphatemia

Bottom Line

View on ClinicalTrials.gov: NCT01571596 ↗

Enrolled (actual)

Serious AEs

13.0%

Results posted

Feb 2021

Primary outcome: Primary: Safety and Efficacy of Repeated SC Injections of KRN23. — 21; 1; 1; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: KRN23 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kyowa Kirin Co., Ltd.
Primary completion: Sep 2013

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	—

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).

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

View full record on ClinicalTrials.gov →

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.