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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The starting dose of KRN23 will be the dose used for the last administration in the preceding studies. The dose may be modified subsequently in accordance with the criteria for dose and dose adjustment.
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
National University Corporation Osaka University
Suita, Osaka, Japan
Number of subjects for each adverse events
Time frame: up to week 140
Effect to Body temperature
Time frame: up to week 140
Effect to Pulse rate
Time frame: up to week 140
Effect to Respiratory rate
Time frame: up to week 140
Effect to Systolic blood pressure in sitting position
Time frame: up to week 140
Effect to Diastolic blood pressure in sitting position
Time frame: up to week 140
Effect to 12-lead electrocardiogram (ECG)
The presence of abnormality in the electrocardiogram
Time frame: up to week 140
Effect to renal ultrasound
The evaluation to nephrocalcinosis in five grades by renal ultrasound
Time frame: up to week 140
Effect to Echocardiogram
The presence of ectopic calcification in the heart by Echocardiogram
Time frame: up to week 140
Concentration of serum phosphorus
Time frame: up to week 140
Concentration of serum 1,25(OH)2D
Time frame: up to week 140
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Toranomon Hospital
Minato-Ku, Tokyo, Japan
Okayama Saiseikai General Hospital
Okayama, Japan
Japan Community Health Care Organization Osaka Hospital
Osaka, Japan
Osaka City University Hospital
Osaka, Japan
Asan Medical Center
Seoul, Korea, South Korea
Seoul National University hospital
Seoul, Korea, South Korea
Concentration of urinary phosphorus
Time frame: up to week 140
Concentration of tubular resorption of phosphorus(TRP)
Time frame: up to week 140
Concentration of maximum tubular reabsorption of phosphate/glomerular filtration rate (TmP/GFR)
Time frame: up to week 140
concentration of Carboxy terminal cross-linked telopeptide of type 1 collagen (CTx) (Adult patients with XLH)
Time frame: up to week 140
concentration of Procollagen type 1 N-propeptide (P1NP) (Adult patients with XLH)
Time frame: up to week 140
concentration of Bone-specific alkaline phosphatase (BALP)(Adult patients with XLH)
Time frame: up to week 140
Concentration of serum alkaline phosphatase (ALP) (Pediatric patients with XLH)
Time frame: up to week 140
Motor functions (6 minutes walk test (6MWT))
Time frame: up to week 140
Radiographic findings of fracture and enthesopathy (Adult patients with XLH)
The presence of radiographic fracture and enthesopathy assessed by X-ray (Adult patients with XLH)
Time frame: up to week 140
Rickets Severity Score (RSS) (Pediatric patients with XLH)
Time frame: up to week 140
Radiographic Global Impression of Change (RGI-C)(Pediatric patients with XLH)
Time frame: up to week 140
Z score of height (LMS method) (Pediatric patients with XLH)
Time frame: up to week 140