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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZG-801 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium value at Double-blind period week4 | Double-blind period baseline to Double-blind period week4 |
| 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 |
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Inclusion Criteria:
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.
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)
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| Name | Affiliation | Role |
|---|---|---|
| Yusuke Tomioka | Zeria Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeria Investigative Site | Hitachi-Naka | Ibaraki | Japan |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Placebo | Drug | Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks. |
|
| 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 |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |