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

  • STATUS
    Recruiting
  • End date
    Feb 21, 2023
  • participants needed
    100
  • sponsor
    Zeria Pharmaceutical
Updated on 21 August 2021

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.

Details
Condition Hyperkalemia
Treatment Placebo, Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
Clinical Study IdentifierNCT04955678
SponsorZeria Pharmaceutical
Last Modified on21 August 2021

Eligibility

Yes No Not Sure

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

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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