A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia (NCT04308096) | Clinical Trial Compass
CompletedPhase 3
A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Japan27 participantsStarted 2018-01-09
Plain-language 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-marketing study:
To evaluate the safety and efficacy of KRN23, which was switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continued treatment
Who can participate
SexALL
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Inclusion criteria
✓. 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.
✓. 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 criteria
✕. 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
What they're measuring
1
Number of subjects for each adverse events
Timeframe: up to week 140
2
Effect to Body temperature
Timeframe: up to week 140
3
Effect to Pulse rate
Timeframe: up to week 140
4
Effect to Respiratory rate
Timeframe: up to week 140
5
Effect to Systolic blood pressure in sitting position
Timeframe: up to week 140
6
Effect to Diastolic blood pressure in sitting position
✕. 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