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A Study of KRN23 in X-linked Hypophosphatemia

Sponsor
Kyowa Hakko Kirin Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00830674
Collaborator
(none)
42
Enrollment
4
Locations
2
Arms
53
Duration (Months)
10.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Dec 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

Primary Outcome Measures

  1. Safety and tolerability [Up to 7 weeks after dosing (maximally 11 weeks)]

    AEs, etc

Secondary Outcome Measures

  1. Effect to pharmacodynamic parameter [Up to 7 weeks after dosing (maximally 11 weeks)]

    Change in Serum Phosphate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Yale University School of Medicine New Haven Connecticut United States 06510
2 General Clinical Research Center, Indiana University School of Medicine Indianapolis Indiana United States 46202-5250
3 Duke Clinical Research Unit Durham North Carolina United States 27710
4 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00830674
Other Study ID Numbers:
  • KRN23-US-02
First Posted:
Jan 28, 2009
Last Update Posted:
Oct 21, 2013
Last Verified:
Oct 1, 2013
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.
XLH
Additional relevant MeSH terms:
Familial Hypophosphatemic Rickets
Hypophosphatemia

Study Results

No Results Posted as of Oct 21, 2013