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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. )

Tracking Information
First Submitted Date  ICMJE January 27, 2009
First Posted Date  ICMJE January 28, 2009
Last Update Posted Date October 21, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]
AEs, etc
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
Change in Serum Phosphate [ Time Frame: Up to 4 weeks after dosing (maximally 6 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]
Change in Serum Phosphate
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of KRN23 in X-linked Hypophosphatemia
Official Title  ICMJE A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE X-linked Hypophosphatemia
Intervention  ICMJE
  • Drug: Placebo
    single dose IV or SC administration
  • 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
Study Arms  ICMJE
  • Experimental: KRN23
    Single IV or SC administration on day 1
    Intervention: Drug: KRN23
  • Placebo Comparator: Placebo
    Single IV or SC administration on day 1
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
42
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2009)
24
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00830674
Other Study ID Numbers  ICMJE KRN23-US-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
Study Sponsor  ICMJE Kyowa Hakko Kirin Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas O. Carpenter, M.D. Yale University
PRS Account Kyowa Kirin Pharmaceutical Development, Inc.
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP