A Phase 4 interventional study of KRN23 in Tumor-Induced Osteomalacia (TIO), sponsored by Kyowa Kirin Co., Ltd.. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in adult Chinese patients with TIO
Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KRN23 administered subcutaneously (SC) every 4 weeks for 48 weeks. The dose varies according to serum phosphorus level which include 0.3,0.6,1.0,1.4 and 2.0 mg/kg.
Drug: KRN23
KRN23 is a sterile clear colourless and preservative free solution supplied in single use 5 mL vials containing 1 mL of KRN23 at a concentration of 30mg/mL
Also known as: Burosumab, Crysvita
Change from Baseline in mean serum phosphorus level at the end of the dosing cycle.
Time frame: Week 20, 24, 28, 32, 36, 40, 44 and 48
Change from Baseline in mean serum phosphorus level.
Time frame: Week 22
Proportion of patients achieving serum phosphorus level above the lower limit of normal (LLN; 2.5 mg/dL [0.81 mmol/L])
Time frame: Week 22
Proportion of patients achieving mean serum phosphorus level above the LLN (2.5 mg/dL [0.81 mmol/L]) at the end of the dose cycle as averaged across dose period
Time frame: Weeks 20, 24, 28, 32, 36, 40, 44 and 48
Change from Baseline in mean level of serum 1,25(OH)2D over time
Time frame: Week 0, 1, 2, 12, 16, 24, 36 and 48
Change from Baseline in mean level of serum creatinine over time
Time frame: Week 0, 4, 8, 12, 16, 24, 36 and 48
Change from Baseline in mean level of urinary phosphorus over time
Time frame: Week 0, 4, 8, 12, 16, 24, 36 and 48
Change from Baseline in level of tubular reabsorption of phosphate(TRP) over time
Time frame: Week 0, 4, 8, 12, 16, 24, 36 and 48
Change from Baseline in ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) over time
Time frame: Week 0, 4, 8, 12, 16, 24, 36 and 48
Change in concentration of alkaline phosphatase (ALP) over time
Time frame: Week 0, 8, 16, 24 and 48
Change in concentration of bone-specific alkaline phosphatase (BALP) over time
Time frame: Week 0, 8, 16, 24 and 48
Change in concentration of carboxy-terminal cross-linked telopeptide of type 1 collagen (CTx) over time
Time frame: Week 0, 8, 16, 24 and 48
Change in concentration of procollagen type 1 N propeptide(P1NP) over time
Time frame: Week 0, 8, 16, 24 and 48
Change in concentration of osteocalcin (OC) over time
Time frame: Week 0, 8, 16, 24 and 48
Change from Baseline in six-minute walking test (6MWT) over time
This test will measure the distance that the subject can walk a previously measured course in a period of 6 minutes.
Time frame: Week 0, 12, 24 and 48
Change from Baseline in Brief Pain Inventory (BPI) score over time
Evaluate the degree of pain and its impact on daily functioning over previous 24 hours, the subject will fill out a 15-item self-administered questionnaire. The BPI evaluates the condition of all pain over the previous 24 hours. Two dimensions are measured: pain severity (worst, least, average, and now) and the impact of pain on functioning (pain interference with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). The severity of pain in the last 24 hours is rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Week 0, 12, 24 and 48
Change from Baseline in Brief Fatigue Inventory (BFI) score over time
Evaluate the degree of fatigue and its impact on daily functioning over previous 24 hours, the subject will fill out a 9-item self-administered questionnaire. Two dimensions are measured: fatigue severity (now, usual and worst) and the impact of fatigue on functioning (fatigue interference with general activity, mood, walking ability, normal work, relations with other people, enjoyment of life). The severity of fatigue in the last 24 hours is rated on a scale of 0 (no fatigue or does not interfere) to 10 (fatigue as bad as you can imagine or completely interferes). Scores are normalized to a 0-10 metric where 0 was the best health state and 90 was the worst.
Time frame: Week 0, 12, 24 and 48
36-item short-form health survey (SF-36) scores to examine health-related Quality of Life
Evaluate physical and mental health status, the subject will fill out a 36-item self-administered questionnaire. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The score will be calculated based on scoring system, and the Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
Time frame: Week 0, 12, 24 and 48
Change from Baseline in bone mineral density over time
Time frame: Week 0, 24 and 48
Radiologic healing or resolution of pre-existing fractures and/or pseudofractures, as defined by skeletal survey at Baseline and subsequent targeted radiography.
Time frame: Week 0, 12, 24, 36 and 48
Radiologic healing or resolution of pre-existing fractures and/or pseudofractures, as defined by skeletal survey at Baseline and 99mTc-labelled bone scan
Time frame: Week 0, 24 and 48
Safety of KRN23 by studying the number of Adverse Events (including laboratory and imaging assessments)
Incidence and frequency of AEs and SAEs, including clinically significant changes in laboratory assessments as well as ECHO, ECG, ultrasound, vital sign, tumor images and Anti-KRN23 antibody.
Time frame: Week 0 to Week 48
Safety of KRN23 by studying the severity of Adverse Events (including laboratory and imaging assessments)
Severity of AEs and SAEs, including clinically significant changes in laboratory assessments as well as ECHO, ECG, ultrasound, vital sign, tumor images and Anti-KRN23 antibody.
Time frame: Week 0 to Week 48
Safety of KRN23 by studying the relatedness of Adverse Events (including laboratory and imaging assessments)
Relatedness between KRN23 and AEs/SAEs, including clinically significant changes in laboratory assessments as well as ECHO, ECG, ultrasound, vital sign, tumor images and Anti-KRN23 antibody.
Time frame: Week 0 to Week 48
Pharmacokinetics: KRN23 concentrations
KRN23 concentration in the Mid and end of dose cycles.
Time frame: Week 0, 1, 2, 4, 16, 20, 22, 24 and 48
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Burosumab
Oncogenic osteomalacia