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Completed

NCT Number: NCT00830674

A Study of KRN23 in X-linked Hypophosphatemia

The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.

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Key information

Conditions

X-linked Hypophosphatemia 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 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

Yale University School of Medicine, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Clinical diagnosis of XLH
  • TmP/GFR is less than 2.0 mg/dL
  • GFR is 60 mL/min or above

Exclusion criteria

  • Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
  • History of known immunodeficiency
  • Lactating females, female patients who are pregnant or planning to become pregnant during the study
  • Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
  • Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
  • Receipt of live (attenuated) vaccine within 3-months prior to screening
  • Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Treatment and study plan

Placebo

Drug

single dose IV or SC administration

KRN23

Drug

Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg

Primary outcomes

  1. Safety and tolerability

    Time frame: Up to 7 weeks after dosing (maximally 11 weeks)

    AEs, etc

Secondary outcomes

  1. Effect to pharmacodynamic parameter

    Time frame: Up to 7 weeks after dosing (maximally 11 weeks)

    Change in Serum Phosphate

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

Registry information

Official study title

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jan 28, 2009
Registry last updated
Jun 17, 2024

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.

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