Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
Conditions
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of switching to the post-marketing study: 1)Voluntary written informed consent to participate in the post-marketing study (if aged < 20 years at the time of consent, written informed consent must be obtained from his or her legally acceptable representative as well) 2)Switching to the post-marketing study is necessary and appropriate for the subject from the viewpoint of efficacy and safety, as judged by the investigator or subinvestigator.
Exclusion criteria
Exclusion criteria: 1) Use of the following drugs within 14 days prior to screening: pharmacologic vitamin D metabolites or analogs, or drugs for treating TIO/ENS including oral phosphate, aluminum hydroxide antacids, acetazolamide, or thiazide diuretics 2) Medication to suppress parathyroid hormone (PTH) (e.g., cinacalcet hydrochloride) within 60 days prior to screening 3) Blood or blood product transfusion within 60 days prior to screening 4) Chemotherapy for TIO or other malignant tumors within 4 months prior to screening 5) History of being positive for human immunodeficiency virus antibody, hepatitis B antigen and/or hepatitis C virus antibody 6) Predisposition to infection, or history of recurrent infection or known immunodeficiency 7) Pregnant or breastfeeding at screening or intention to become pregnant during the study; for male subjects, the partner's intention to become pregnant during the study 8) Use of an investigational product or device within 4 months prior to screening, or planning to receive other investigational product before completing all assessments in this study 9) Use of therapeutic monoclonal antibodies including KRN23 within 90 days prior to screening 10) History of allergic or anaphylactic reactions to KRN23, any of the KRN23 ingredients, or any other monoclonal antibodies 11) Anyone otherwise considered unsuitable participation in the study by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Serum phosphorus concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| safety laboratory tests | — |
Countries
Asia except Japan, Japan
Outcome results
None listed