A Study of KRN23 in X-linked Hypophosphatemia

NCT00830674 | Completed Phase 1 DMC

• 1 other identifier: KRN23-US-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

X-linked Hypophosphatemia

Keywords

XLH

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  AEs, etc

  Up to 7 weeks after dosing (maximally 11 weeks)

Secondary Outcomes (1)

• Effect to pharmacodynamic parameter

  Up to 7 weeks after dosing (maximally 11 weeks)

Study Arms (2)

KRN23

EXPERIMENTAL

Single IV or SC administration on day 1

Drug: KRN23

Placebo

PLACEBO COMPARATOR

Single IV or SC administration on day 1

Drug: Placebo

Interventions

Placebo DRUG

single dose IV or SC administration

Placebo

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

KRN23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (4)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

General Clinical Research Center, Indiana University School of Medicine

Indianapolis, Indiana, 46202-5250, United States

Location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Carpenter TO, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Wooddell MM, Kawakami T, Ito T, Zhang X, Humphrey J, Insogna KL, Peacock M. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 2014 Apr;124(4):1587-97. doi: 10.1172/JCI72829. Epub 2014 Feb 24.

  PMID: 24569459 DERIVED

Related Links

• KRN23-INT-002 An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

MeSH Terms

Conditions

Familial Hypophosphatemic Rickets

Interventions

burosumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas O. Carpenter, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2013
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (4)