A Study of KRN23 in X-linked Hypophosphatemia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

ClinicalTrials.gov Identifier:

NCT00830674

First received: January 27, 2009

Last updated: October 18, 2013

Last verified: October 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
X-linked Hypophosphatemia	Drug: Placebo Drug: KRN23	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary hypophosphatemic rickets

Genetic and Rare Diseases Information Center resources: X-linked Hypophosphatemia Hypophosphatemic Rickets Rickets

U.S. FDA Resources

Further study details as provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):

Primary Outcome Measures:

Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]
AEs, etc

Secondary Outcome Measures:

Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]
Change in Serum Phosphate


Enrollment:	42
Study Start Date:	December 2008
Study Completion Date:	May 2013
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: KRN23 Single IV or SC administration on day 1	Drug: KRN23 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
Placebo Comparator: Placebo Single IV or SC administration on day 1	Drug: Placebo single dose IV or SC administration

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830674

Locations


United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Indiana
General Clinical Research Center, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202-5250
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030

Sponsors and Collaborators

Kyowa Hakko Kirin Pharma, Inc.

Investigators


Principal Investigator:	Thomas O. Carpenter, M.D.	Yale University

More Information

Additional Information:

KRN23-INT-002 An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00830674 History of Changes
Other Study ID Numbers:	KRN23-US-02
Study First Received:	January 27, 2009
Last Updated:	October 18, 2013

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):


XLH

Additional relevant MeSH terms:


Hypophosphatemia Familial Hypophosphatemic Rickets Phosphorus Metabolism Disorders Metabolic Diseases Rickets, Hypophosphatemic Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Hypophosphatemia, Familial Renal Tubular Transport, Inborn Errors	Kidney Diseases Urologic Diseases Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Calcium Metabolism Disorders Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders

ClinicalTrials.gov processed this record on June 23, 2017

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