A Study of KRN23 in X-linked Hypophosphatemia

October 18, 2013 updated by: Kyowa Hakko Kirin Pharma, Inc.

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5250
        • General Clinical Research Center, Indiana University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Unit
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Up to 7 weeks after dosing (maximally 11 weeks)
AEs, etc
Up to 7 weeks after dosing (maximally 11 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect to pharmacodynamic parameter
Time Frame: Up to 7 weeks after dosing (maximally 11 weeks)
Change in Serum Phosphate
Up to 7 weeks after dosing (maximally 11 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Hakko Kirin Pharma, Inc.

Investigators

  • Principal Investigator: Thomas O. Carpenter, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (ESTIMATE)

January 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRN23-US-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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