Back to resultsA Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
Primary Purpose
X-linked Hypophosphatemic Rickets/Osteomalacia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KRN23
Sponsored by
About this trial
This is an interventional treatment trial for X-linked Hypophosphatemic Rickets/Osteomalacia focused on measuring XLH
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Patients with XLH
Exclusion Criteria:
- Have an active infection or chronic inflammatory disease
- Have uncontrolled hypertension
- Have uncontrolled diabetes mellitus
- History of known immunodeficiency
- Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
- 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
- Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KRN23
Arm Description
Single SC administration on day 1
Outcomes
Primary Outcome Measures
Number and types of adverse events
The safety of KRN23 assessed by number and types of adverse events, laboratory tests
Secondary Outcome Measures
Profiles of pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181764
Brief Title
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
Official Title
A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
X-linked Hypophosphatemic Rickets/Osteomalacia
Keywords
XLH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KRN23
Arm Type
Experimental
Arm Description
Single SC administration on day 1
Intervention Type
Drug
Intervention Name(s)
KRN23
Intervention Description
Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg
Primary Outcome Measure Information:
Title
Number and types of adverse events
Description
The safety of KRN23 assessed by number and types of adverse events, laboratory tests
Time Frame
Up to 7 weeks after dosing
Secondary Outcome Measure Information:
Title
Profiles of pharmacokinetics
Time Frame
Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Patients with XLH
Exclusion Criteria:
Have an active infection or chronic inflammatory disease
Have uncontrolled hypertension
Have uncontrolled diabetes mellitus
History of known immunodeficiency
Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
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
Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception
Facility Information:
City
Tokyo
Country
Japan
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
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