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

Kyowa Kirin Co., Ltd.6 sites in 2 countries23 target enrollmentFebruary 2012

ConditionsX-linked Hypophosphatemia

InterventionsKRN23

DrugsKRN23

Overview

Phase: Phase 1
Intervention: KRN23
Conditions: X-linked Hypophosphatemia
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 23
Locations: 6
Primary Endpoint: Safety and Efficacy of Repeated SC Injections of KRN23.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

June 2014

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

KRN23

Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)

Intervention: KRN23

Outcomes

Primary Outcomes

Safety and Efficacy of Repeated SC Injections of KRN23.

Time Frame: 13.5 months,(50 visits)

Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.