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

University of California - San Francisco

533 Parnassus Ave
San Francisco, California 94122

(415) 476-9000