Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Phase 2

Completed

• Conditions: Hyperkalemia

• Registration Number: JPRN-jRCT2080224547
• Lead Sponsor: Zeria Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Study Completion: 2021-02-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Informed consent given
- Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Nondialysis patients) or 5.5 to < 6.5 mEq/L (Dialysis patients)

Exclusion Criteria

- Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
- Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
- Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
- Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
- Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
- Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
- Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
- Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Change in serum potassium 4 weeks after the start of administration in each group of starting dose<br>efficacy<br>Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each<br>group of starting dose<br>safety<br>Incidence of adverse events<br>safety<br>Incidence of adverse drug reactions