A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome (NCT02722798) | Clinical Trial Compass
CompletedPhase 2
A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
Japan, South Korea14 participantsStarted 2016-04
Plain-language summary
Before switching to the post-marketing study:
To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter, open-label, intraindividual dose adjustment study.
After switching to the post-marketing study:
To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continue treatment after the marketing approval of KRN23 in Japan.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥ 18 years
✓. Diagnosis of Tumor-Induced Osteomalacia(TIO) or Epidermal Nevus Syndrome(ENS) and not amenable to receive surgical excision of the offending tumor/lesion
✓. Serum phosphorus level \< 2.5 mg/dL
✓. Serum FGF23 level ≥ 100 pg/mL
✓. Ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate\< 2.5 mg/dL
✓. Estimated glomerular filtration rate (eGFR) at screening ≥ 60 mL/min/1.73 m2, or eGFR ≥ 30 and \< 60 mL/min/1.73 m2 with an evidence of no renal failure related to nephrocalcinosis
✓. Corrected serum calcium level \< 10.8 mg/dL
✓. For female subjects of childbearing potential; negative urine pregnancy test and willingness to undergo additional pregnancy tests during the study
Exclusion criteria
✕. 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
What they're measuring
1
serum phosphorus concentration at each test time point
✕. Medication to suppress parathyroid hormone (PTH) within 60 days prior to screening
✕. Blood or blood product transfusion within 60 days prior to screening
✕. Chemotherapy for TIO or other malignant tumors within 4 months prior to screening
✕. History of being positive for human immunodeficiency virus antibody, hepatitis B antigen and/or hepatitis C virus antibody
✕. Predisposition to infection, or history of recurrent infection or known immunodeficiency
✕. 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
✕. 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