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A Study of KRN23 in X-linked Hypophosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00830674
First received: January 27, 2009
Last updated: December 6, 2011
Last verified: December 2011
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 (XLH)
 Drug: Placebo
Drug: KRN23
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ] [ Designated as safety issue: Yes ]
    AEs, etc


Secondary Outcome Measures:
  • Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ] [ Designated as safety issue: No ]
    Change in Serum Phosphate


Enrollment: 42
Study Start Date: December 2008
Study Completion Date: December 2011
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
Genders Eligible for Study:   Both
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
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

No publications provided

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: December 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
XLH

Additional relevant MeSH terms:
Hypophosphatemia
Hypophosphatemic Rickets, X-Linked Dominant
Phosphorus Metabolism Disorders
Metabolic Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
 Urologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 18, 2012