Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

Study Overview
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Brief Summary
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To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding 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: Patients with stable chronic renal failure who have undergone hemodialysis three 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. Taking phosphate binders three times per day. 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 or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. Exclusion Criteria: 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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis). Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) 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 (relocate to another hospital/clinic) during the study period. Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- |
| Experimental: KHK7791 A<br>Patients take KHK7791 low dose BID. | Drug: KHK7791<br>* oral administration<br>|
| Experimental: KHK7791 B<br>Patients take KHK7791 middle dose BID. | Drug: KHK7791<br>* oral administration<br>|
| Experimental: KHK7791 C<br>Patients take KHK7791 high dose BID. | Drug: KHK7791<br>* oral administration<br>|
| Experimental: KHK7791 D<br>Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question. | Drug: KHK7791<br>* oral administration<br>|
| Placebo Comparator: Placebo<br>Patients take Placebo BID. | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6. |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum Ca × P levels from baseline. |  | Week 6 | 
| Changes in corrected serum calcium levels from baseline. |  | Week 6 | 

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