A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.

Official Title
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ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -

Conditions
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Hyperkalemia

Intervention / Treatment
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* Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose serum potassium value (local) at the Run-in period baseline is ≥5.5mEq/L, < 6.5 mEq/L Age 20 - 80 years old at informed consent Patients who understand an overview of the study and voluntarily consented to participate in the study by documents. Main Exclusion Criteria: Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline Patients with poorly controlled blood pressure Patients with heart failure in New York Heart Association Class IV Patients who have experienced heart transplant, liver transplant or kidney transplant or who are predicted that the need for them will occur during the study Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated. Sodium polystyrene sulfonate Calcium polystyrene sulfonate Sodium zirconium cyclosilicate hydrate Potassium supplement Patients with or who have experienced a severe swallowing disorder, moderate to severe gastroparesis, severe constipation, bowel obstruction, incarceration, abnormal post-operative bowel motility disorders or severe gastrointestinal disorders. In addition, patients who have experienced bariatric surgery or major gastrointestinal surgery (e.g., bowel resection). Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZG-801<br> | Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes<br>* ZG-801 is powder for suspension. In Run-in period, ZG-801 is taken once a day for 4 or 5 weeks. In Double-blind period, ZG-801 is taken once a day for 4 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum potassium value at Double-blind period week4 |  | Double-blind period baseline to Double-blind period week4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of serum potassium value within 3.5 mEq/L to < 5.1 mEq/L or within 3.5 mEq/L to <5.5 mEq/L in Double-blind Period |  | Double-blind period baseline to Double-blind period week4 | 
| Time to First Non-maintenance of Serum Potassium Value in Double-blind Period |  | Double-blind period baseline to Double-blind period week4 | 
| RAASi dose sustaining proportion |  | Double-blind period baseline to Double-blind period week4 | 
| Change in Serum Potassium Value |  | Run-in period baseline to Run-in period week 5 |