Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Study Overview
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Brief Summary
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To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.

Official Title
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: KHK7791
* Drug: Placebo


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 (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), 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. 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 or cardiovascular disease requiring hospitalization within 6 months before screening examination. Uncontrollable hypertension or diabetes. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period. Any diagnosis of and 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KHK7791<br>During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. | Drug: KHK7791<br>* oral administration<br>|
| Placebo Comparator: Placebo<br>During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration. |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum phosphorous levels from baseline values at each time point. |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0). |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved. |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5). |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved. |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Concentrations of such as Ca × P product levels at each time point. |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 
| Changes of such as Ca × P product levels from baseline values at each time point. |  | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | 

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