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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
serum phosphorus concentration at each test time point
. 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
. 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