NCT01340482

A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• X-linked Hypophosphatemia

Interventions

Type	Name	Description
DRUG	KRN23	Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2011-04-22
• Last updated: 2024-06-18
• Results posted: 2020-10-26

Locations

6 sites across 2 countries: United States, Canada