Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia (NCT03822507) | Clinical Trial Compass
CompletedPhase 3
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
China, Hong Kong, South Korea404 participantsStarted 2019-04-09
Plain-language summary
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
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
. Personally submitted written voluntary informed consent to participate in the study
. Aged ≧18 years at the time of consent
. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
. Intact PTH level (centrally measured) of \>300 pg/mL at screening
. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening
Exclusion criteria
. Treatment with cinacalcet hydrochloride within 2 weeks before screening
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
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)