NCT04955678

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkalemia

Interventions

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

Timeline

• Start date: 2021-08-03
• Primary completion: 2022-12-26
• Completion: 2023-03-13
• First posted: 2021-07-09
• Last updated: 2023-04-20

Locations

1 site across 1 country: Japan