A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -
Actual Study Start Date: August 3, 2021
Estimated Primary Completion Date: December 2022
Estimated Study Completion Date: February 2023
Arm:
- Experimental: ZG-801
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 100 |
| Actual Study start date | 03 August 2021 |
| Estimated Study Completion Date | 01 February 2023 |