Status:
COMPLETED
Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Hyperkalemia
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients. To evaluate the safety of ZG-801 for the chronic...
Eligibility Criteria
Inclusion
- Males and females ages 18 - 80
- Informed consent given
- Serum Potassium measurement at baseline is 5.1 to \< 6.5 mEq/L (Non-dialysis patients or 5.5 to \< 6.5 mEq/L (Dialysis patients)
Exclusion
- 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
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03799926
Start Date
February 18 2019
End Date
February 2 2021
Last Update
March 25 2021
Active Locations (1)
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1
Zeria Investigative Sites
Kanagawa, Japan