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A Study of KRN23 in X-linked Hypophosphatemia

Primary Purpose

X-linked Hypophosphatemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

KRN23

About this trial

This is an interventional treatment trial for X-linked Hypophosphatemia focused on measuring XLH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older
Clinical diagnosis of XLH
TmP/GFR is less than 2.0 mg/dL
GFR is 60 mL/min or above

Exclusion Criteria:

Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
History of known immunodeficiency
Lactating females, female patients who are pregnant or planning to become pregnant during the study
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
Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
Receipt of live (attenuated) vaccine within 3-months prior to screening
Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Sites / Locations

Yale University School of Medicine
General Clinical Research Center, Indiana University School of Medicine
Duke Clinical Research Unit
University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KRN23

Placebo

Arm Description

Single IV or SC administration on day 1

Outcomes

Primary Outcome Measures

Safety and tolerability

AEs, etc

Secondary Outcome Measures

Effect to pharmacodynamic parameter

Change in Serum Phosphate

Full Information

NCT ID

NCT00830674

First Posted

January 27, 2009

Last Updated

October 18, 2013

Sponsor

Kyowa Hakko Kirin Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00830674

Brief Title

A Study of KRN23 in X-linked Hypophosphatemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Hakko Kirin Pharma, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

X-linked Hypophosphatemia

Keywords

XLH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KRN23

Arm Type

Experimental

Arm Description

Single IV or SC administration on day 1

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single IV or SC administration on day 1

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

single dose IV or SC administration

Intervention Type

Drug

Intervention Name(s)

KRN23

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

AEs, etc

Time Frame

Up to 7 weeks after dosing (maximally 11 weeks)

Secondary Outcome Measure Information:

Title

Effect to pharmacodynamic parameter

Description

Change in Serum Phosphate

Time Frame

Up to 7 weeks after dosing (maximally 11 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older Clinical diagnosis of XLH TmP/GFR is less than 2.0 mg/dL GFR is 60 mL/min or above Exclusion Criteria: Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening History of known immunodeficiency Lactating females, female patients who are pregnant or planning to become pregnant during the study 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 Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing Receipt of live (attenuated) vaccine within 3-months prior to screening Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas O. Carpenter, M.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

General Clinical Research Center, Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202-5250

Country

United States

Facility Name

Duke Clinical Research Unit

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24569459

Citation

Carpenter TO, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Wooddell MM, Kawakami T, Ito T, Zhang X, Humphrey J, Insogna KL, Peacock M. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 2014 Apr;124(4):1587-97. doi: 10.1172/JCI72829. Epub 2014 Feb 24.

Results Reference

derived

Links:

URL

http://www.clinicaltrials.gov/ct2/show/NCT01340482?term=KRN23&rank=1

Description

KRN23-INT-002 An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

Learn more about this trial

A Study of KRN23 in X-linked Hypophosphatemia

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