A Study of KRN23 in Subjects With X-linked Hypophosphatem... | NCT02181764

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

NCT02181764

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

15Actual

Phase

Phase 1

Conditions

X-linked Hypophosphatemic Rickets/Osteomalacia

Interventions

KRN23

Countries

Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 2, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KRN23	Experimental	Single SC administration on day 1	Drug: KRN23

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KRN23	Drug	Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg	KRN23

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and types of adverse events	The safety of KRN23 assessed by number and types of adverse events, laboratory tests	Up to 7 weeks after dosing

Secondary Outcomes

Measure	Description	Time Frame
Profiles of pharmacokinetics		Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39151033	Derived	Portale AA, Ward L, Dahir K, Florenzano P, Ing SW, Jan de Beur SM, Martin RM, Meza-Martinez AI, Paloian N, Ashraf A, Dixon BP, Khan A, Langman C, Chen A, Wang C, Roberts MS, Tandon PK, Bedrosian C, Imel EA. Nephrocalcinosis and kidney function in children and adults with X-linked hypophosphatemia: baseline results from a large longitudinal study. J Bone Miner Res. 2024 Sep 26;39(10):1493-1502. doi: 10.1093/jbmr/zjae127.

Facility	Status	City	State	ZIP	Country	Contacts
		Tokyo			Japan

ID	Term
D053098	Familial Hypophosphatemic Rickets
D010018	Osteomalacia

ID	Term
D063730	Rickets, Hypophosphatemic
D012279	Rickets
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases