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

Hyperkalemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955678
• Other study ID #: ZG-801-02
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: October 2022
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 13, 2023
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

1. Sodium polystyrene sulfonate

2. Calcium polystyrene sulfonate

3. Sodium zirconium cyclosilicate hydrate

4. 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)

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

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
Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.

Locations

Country	Name	City	State
Japan	Zeria Investigative Site	Hitachinaka	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum potassium value at Double-blind period week4		Double-blind period baseline to Double-blind period week4
Secondary	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
Secondary	Time to First Non-maintenance of Serum Potassium Value in Double-blind Period		Double-blind period baseline to Double-blind period week4
Secondary	RAASi dose sustaining proportion		Double-blind period baseline to Double-blind period week4
Secondary	Change in Serum Potassium Value		Run-in period baseline to Run-in period week 5