Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis (NCT04766398) | Clinical Trial Compass
CompletedPhase 3
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Japan169 participantsStarted 2021-03-15
Plain-language summary
To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.
Who can participate
Age range
20 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
. Has voluntarily provided written informed consent to participate in the study.
. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
. Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
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
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
. If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Exclusion criteria
. Peritoneal dialysis was performed within 12 weeks before screening examination.
. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
. Having concurrent severe heart disease or hepatic impairment.
. Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.