A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ZG-801
|
Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
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.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change in serum potassium value at Double-blind period week4 [Double-blind period baseline to Double-blind period week4]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients whose serum potassium value (local) at the Run-in period baseline is ≥5.5mEq/L, < 6.5 mEq/L
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Age 20 - 80 years old at informed consent
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Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.
Main Exclusion Criteria:
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Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
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Patients with poorly controlled blood pressure
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Patients with heart failure in New York Heart Association Class IV
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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
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Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
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Sodium polystyrene sulfonate
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Calcium polystyrene sulfonate
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Sodium zirconium cyclosilicate hydrate
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Potassium supplement
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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).
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Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zeria Investigative Site | Hitachinaka | Ibaraki | Japan |
Sponsors and Collaborators
- Zeria Pharmaceutical
Investigators
- Study Director: Yusuke Tomioka, Zeria Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZG-801-02