A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.

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Key information

Conditions

X-linked Hypophosphatemic Rickets/Osteomalacia Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Familial Hypophosphatemic Rickets Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypophosphatemia Hypophosphatemia, Familial Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteomalacia Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Rickets Rickets, Hypophosphatemic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
Patients with XLH

Exclusion criteria

Have an active infection or chronic inflammatory disease
Have uncontrolled hypertension
Have uncontrolled diabetes mellitus
History of known immunodeficiency
Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening
Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

Treatment and study plan

KRN23

Drug

Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg

Primary outcomes

Number and types of adverse events

Time frame: Up to 7 weeks after dosing

The safety of KRN23 assessed by number and types of adverse events, laboratory tests

Secondary outcomes

Profiles of pharmacokinetics

Time frame: Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 4, 2014
Registry last updated: Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed