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

Status:	Completed
Conditions:	Other Indications, Metabolic
Therapuetic Areas:	Pharmacology / Toxicology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	10/19/2013
Start Date:	February 2012
End Date:	November 2014
Contact:	Amy Zhang, PhD
Email:	azhang@kyowa-kirin-pharma.com
Phone:	609-919-1100

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

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, bone quality and histomorphometric parameters.

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 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

We found this trial at

sites

Clinical Research Center, Indiana University School of Medicine

Indianapolis, Indiana 46202

from

Indianapolis, IN