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CompletedNCT02181764Updated Mar 3, 2017

A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

A Phase 1 interventional study of KRN23 in X-linked Hypophosphatemic Rickets/Osteomalacia, sponsored by Kyowa Kirin Co., Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.

02

Conditions studied

  • X-linked Hypophosphatemic Rickets/Osteomalacia

Keywords

  • XLH
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 years or older
  2. Patients with XLH

Exclusion criteria

Exclusion Criteria:

  1. Have an active infection or chronic inflammatory disease
  2. Have uncontrolled hypertension
  3. Have uncontrolled diabetes mellitus
  4. History of known immunodeficiency
  5. Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
  6. Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening
  7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    KRN23

    Single SC administration on day 1

    Drug: KRN23

Interventions

  • DrugKRN23

    Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg

05

What researchers measure

Primary outcomes

  1. Number and types of adverse events

    The safety of KRN23 assessed by number and types of adverse events, laboratory tests

    Time frame: Up to 7 weeks after dosing

Secondary outcomes

  1. Profiles of pharmacokinetics

    Time frame: Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose

06

Study locations

2 sites
  • Tokyo, Japan
  • Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT02181764
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Jul 4, 2014
Start date
Jul 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Mar 3, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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