Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Study Overview
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Brief Summary
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To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.

Official Title
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A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: KHK7791


Participation Criteria
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Eligibility Criteria
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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 ≤ 7.0 mg/dL at screening examination. 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 patient's medical records before pre-enrollment) History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) 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. Severe heart disease, hepatic impairment, or concurrent cirrhosis. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination. Uncontrollable hypertension or diabetes Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period. Any diagnosis of or treatment of malignancy within 5 years before screening examination.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK7791<br>During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test. KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible. | Drug: KHK7791<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks. | To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia. | Dose period Week 1 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment. | To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis. Important secondary endpoint | Week 1 52 | 
| Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment. |  | Week 1 52 | 
| Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment. |  | Week 1 52 | 
| The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment. |  | Week 1 52 | 
| The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment. |  | Week 1 52 | 
| Concentration of serum phosphorous levels values at each time point. |  | Week 1 52 | 
| Change of serum phosphorous levels from baseline values at each time point. |  | Week 1 52 | 
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0). |  | Week 1 52 | 
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved. |  | Week 1 52 | 
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5). |  | Week 1 52 | 
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved. |  | Week 1 52 | 
| Concentrations of such as Ca × P product levels at each time point. |  | Week 1 52 | 
| Changes of such as Ca × P product levels from baseline values at each time point. |  | Week 1 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenapanor, Hyperphosphatemia, Hemodialysis