Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With… (NCT05357573) | Clinical Trial Compass
CompletedPhase 4
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO
China9 participantsStarted 2022-09-07
Plain-language summary
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in adult Chinese patients with TIO
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
. Have a clinical diagnosis of TIO based on evidence of excessive FGF23 that is not amenable to cure by surgical excision of the offending tumor (documented by Investigator)
. Male or female Chinese patients aged ≥18 years at the time of signing the informed consent form
. Have a fasting serum phosphorus level \< 2.5 mg/dL (0.81 mmol/L) at Screening
. Have a serum iFGF23 level ≥ 100 pg/mL by Kainos assay at Screening
. Have a TmP/GFR \< 2.5 mg/dL at Screening
. Have an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2(using CKD-EPI formula) at Screening. Subjects with an eGFR ≥ 30 but \< 60 mL/min at screening will be considered eligible so long as in the opinion of the Investigator the decline in renal function is not related to nephrocalcinosis
. Have a corrected serum calcium level \< 10.8 mg/dL (2.69 mmol/L) at Screening (Corrected serum calcium = serum calcium in mg/dL + 0.8 × \[4 - serum albumin in g/dL\])
. Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female patients of child-bearing potential only)
Exclusion criteria
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
Change from Baseline in mean serum phosphorus level at the end of the dosing cycle.
. Use of the following drugs within 14 days prior to screening: pharmacologic vitamin D metabolites or analogs, or drugs for treating TIO including oral phosphate, aluminum hydroxide antacids, acetazolamide, or thiazide diuretics
. Medication to suppress parathyroid hormone (PTH) (e.g., cinacalcet hydrochloride) within 60 days prior to screening
. Blood or blood product transfusion within 60 days prior to screening
. History of malignancy within 5 years of study entry with the exception of PMT-MCT (phosphaturic mesenchymal tumors of the mixed connective tissue type)
. Positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibody at Screening, or prior history of positive test
. 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 (IP) or device within 4 months prior to screening, or planning to receive other IP before completing all assessments in this study.