A Study of KRN23 in X-Linked Hypophosphatemia

This study is currently recruiting participants.

Verified by Kyowa Hakko Kirin Pharma, Inc., January 2009

First Received: January 27, 2009 No Changes Posted

Sponsored by:	Kyowa Hakko Kirin Pharma, Inc.
Information provided by:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00830674

Purpose

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

Condition	Intervention	Phase
X-Linked Hypophosphatemia (XLH)	Drug: Placebo Drug: KRN23	Phase I

Genetics Home Reference related topics: L1 syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase I, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose-Escalation Study of KRN23 in X-Linked Hypophosphatemia

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:

Change in Serum Phosphate [ Time Frame: Up to 4 weeks after dosing (maximally 6 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
KRN23: Experimental Single IV administration on day 1	Drug: KRN23 Single IV administration on day 1, Doses to be administered are 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg.
2: Placebo Comparator Single IV administration on day 1	Drug: Placebo single dose IV administration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of XLH (documented by Investigator)
Have a value of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate that is less than 2.0 mg/dL at screening
GFR 60 mL/min at screening

Exclusion Criteria:

Intact PTH level greater than 120 pg/mL at screening
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
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

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

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Rebecca Sullivan, MS, RD 203-737-1656 becky.sullivan@yale.edu
Principal Investigator: Thomas O. Carpenter, M.D.
United States, Indiana
General Clinical Research Center, Indiana University School of Medicine	Recruiting
Indianapolis, Indiana, United States, 46202-5250
Contact: Connie Sullivan, RN, CCRC 317-274-8431 csulliv1@iupui.edu
Principal Investigator: Munro Peacock, M.B.
United States, North Carolina
Duke Clinical Research Unit	Recruiting
Durham, North Carolina, United States, 27710
Contact: Margaret Stewart, RN margaret.a.stewart@duke.edu
Principal Investigator: Thomas J. Weber, M.D.

Sponsors and Collaborators

Kyowa Hakko Kirin Pharma, Inc.

Investigators

Principal Investigator:

Thomas O. Carpenter, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Kyowa Hakko Kirin Pharma, Inc ( Carolyn C. Huntenburg, Ph.D., V.P. )
Study ID Numbers:	KRN23-US-02
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00830674 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:

XLH

Study placed in the following topic categories:

Vitamin D Deficiency
Metabolic Diseases
Avitaminosis
Bone Diseases, Metabolic
Hypophosphatemic Rickets, X-Linked Dominant
Bone Diseases
Vitamin D Resistant Rickets
Metabolism, Inborn Errors
Malnutrition
Musculoskeletal Diseases
Urologic Diseases

Genetic Diseases, Inborn
Rickets
Hypophosphatemic Rickets
Hypophosphatemia, Familial
Genetic Diseases, X-Linked
Nutrition Disorders
Hypophosphatemia
Kidney Diseases
Metabolic Disorder
Deficiency Diseases

Additional relevant MeSH terms:

Vitamin D Deficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Avitaminosis
Bone Diseases, Metabolic
Hypophosphatemic Rickets, X-Linked Dominant
Renal Tubular Transport, Inborn Errors
Metal Metabolism, Inborn Errors
Bone Diseases
Calcium Metabolism Disorders
Metabolism, Inborn Errors

Malnutrition
Genetic Diseases, Inborn
Musculoskeletal Diseases
Urologic Diseases
Rickets
Hypophosphatemia, Familial
Genetic Diseases, X-Linked
Nutrition Disorders
Hypophosphatemia
Kidney Diseases
Deficiency Diseases

ClinicalTrials.gov processed this record on May 06, 2009