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A Study of KRN23 in X-linked Hypophosphatemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00830674
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
X-linked Hypophosphatemia Drug: Placebo Drug: KRN23 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : December 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
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


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


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


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

Inclusion Criteria:

  1. 18 years or older
  2. Clinical diagnosis of XLH
  3. TmP/GFR is less than 2.0 mg/dL
  4. GFR is 60 mL/min or above

Exclusion Criteria:

  1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
  2. History of known immunodeficiency
  3. Lactating females, female patients who are pregnant or planning to become pregnant during the study
  4. 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
  5. Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
  6. Receipt of live (attenuated) vaccine within 3-months prior to screening
  7. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830674


Locations
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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
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Principal Investigator: Thomas O. Carpenter, M.D. Yale University
More Information
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Additional Information:

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

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Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00830674    
Other Study ID Numbers: KRN23-US-02
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013
Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):
XLH
Additional relevant MeSH terms:
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Familial Hypophosphatemic Rickets
Hypophosphatemia
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