Status:
COMPLETED
A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
XLH
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Before switching to the post-marketing study: Assess the efficacy and safety of KRN23 administered subcutaneously once every 4 or 2 weeks in adult or children with XLH After switching to the post-ma...
Eligibility Criteria
Inclusion
- Personally submitted voluntary written informed consent to participate in the study; For pediatric patients, personally submitted voluntary written informed consent by a legally authorized representative.
- If appropriate, written or verbal assent to participate in the study should be obtained from patients.
- Patients meeting any of the followings;
- For adult XLH patients, completion the final observation at Week 96 in UX023-CL303 or UX023-CL304
- For pediatric patients, completion the final observation at Week 64 in UX023-CL301
- For female patients; women of childbearing potential (except for females who have not reached menarche, permanently sterilized, postmenopausal \[12 months with no menses without an alternative medical cause\] or anatomically not of childbearing potential) with negative pregnancy test at pre-treatment assessment of Week 0
- For female patient with childbearing potential, or male patients with reproductive capacity; willingness to use acceptable methods of contraception while participating in the study
- Willingness and ability to cooperatively complete all study procedures, adhere to the visit schedule and follow the investigator's instructions, as considered by investigator or subinvestigator
Exclusion
- Use of oral phosphate for treating XLH, pharmacologic vitamin D metabolites or analogs, aluminum hydroxide antacids, systemic corticosteroids, acetazolamide, and thiazides within 7 days prior to scheduled initial administration of investigational drug
- Planned or recommended orthopedic surgery (implantation or removal), including staples, 8 plates or osteotomy, during the study period
- Blood or blood product transfusion within 60 days prior to scheduled initial administration of investigational drug
- Use of growth hormone therapy within 12 months prior to scheduled initial administration of investigational drug
- Use of medication to suppress the secretion of parathyroid hormone (e.g., cinacalcet) within 60 days prior to scheduled initial administration of investigational drug
- Use of any investigational product (except for investigational product of the preceding study) or investigational medical device within 4 months prior to scheduled initial administration of investigational drug, or requirement for any investigational agent prior to completion of all scheduled study assessments
- Use of a therapeutic monoclonal antibody other than KRN23 within 90 days prior to scheduled initial administration of investigational drug
- History of being positive for HIV antibody, HBs antigen and/or HCV antibody
- Anyone otherwise considered unsuitable for the study by the investigator or subinvestigator
- At the time of switching to the post-marketing clinical study:
- Subjects eligible for enrollment in the post-marketing clinical study must have met both of the following criteria:
- Personally submitted voluntary written informed consent to participate in the postmarketing clinical study. For pediatric patients, personally submitted voluntary written informed consent by a legally authorized representative. If appropriate, written or verbal assent to participate in the post-marketing clinical study was to be obtained from subjects.
- Switching to the post-marketing clinical study was necessary and appropriate for the subject from the viewpoint of efficacy and safety, as judged by the investigator or subinvestigator
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04308096
Start Date
January 9 2018
End Date
December 4 2020
Last Update
September 6 2022
Active Locations (10)
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1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
2
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
3
National University Corporation Osaka University
Suita, Osaka, Japan
4
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan