A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia

Kyowa Kirin Co., Ltd.6 sites in 2 countries29 target enrollmentApril 2011

ConditionsX-linked Hypophosphatemia

InterventionsKRN23

DrugsKRN23

Overview

Phase: Phase 1
Intervention: KRN23
Conditions: X-linked Hypophosphatemia
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 29
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). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

October 2013

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

•18 years or older
•Clinical diagnosis of XLH
•TmP/GFR \< 2.0 mg/dL
•GFR ≥60 mL/min
•Corrected Ca \<10.8 mg/dL
•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

•Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
•History of known immunodeficiency
•Pregnant or lactating females subjects or female planning to be become pregnant during the study
•Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
•Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
•Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
•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 4 doses)

Intervention: KRN23

Outcomes

Primary Outcomes

Safety and Efficacy of Repeated SC Injections of KRN23

Time Frame: On-Treatment: 6.5 months, 27 total 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.