A comparative study of ZG-801 and placebo in patients with Hyperkalemia

JRCT ID: jRCT2031210188

Registered date:09/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hyperkalemia
• Date of first enrollment: 03/08/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

1) Run-in period
Subject takes ZG-801 once daily. The starting dose of ZG-801 is 8.4 g/day. From the Run-in period week 1 to week 3, the dose will be adjusted based on the serum potassium value (local) at prescribed visit. Only for subjects who do not meet the transition criteria at the Run-in period week 4, the dose can be adjusted at the Run-in period week 4. The dose titration range of ZG-801 is 8.4 g/day to 25.2g/day.
2) Double-blind period
Subjects take a randomly assigned ZG-801 or placebo once daily. The dose in the Double-blind period shall be the dose at the transition to the Double-blind period and shall not be changed during the Double-blind period.

Outcome(s)

• Primary Outcome: Change in serum potassium value at Double-blind period week4

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients whose serum potassium value (local) at the Run-in period baseline is >=5.5mEq/L, < 6.5 mEq/L
2) Age 20 - 80 years old at informed consent
3) Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.

Exclude criteria

1) Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
2) Patients with poorly controlled blood pressure
3) Patients with heart failure in New York Heart Association Class IV
4) 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
5) Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
a) Sodium polystyrene sulfonate
b) Calcium polystyrene sulfonate
c) Sodium zirconium cyclosilicate hydrate
d) Potassium supplement
6) Patients whose last measured eGFR within 90 days prior to the Run-in period baseline is >= 60mEq/L (calculated by using the serum creatinine value measured at local laboratory). When eGFR has not been measured within 90 days prior to the Run-in period baseline, it must be measured until the Run-in period baseline.
7) 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).
8) Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)

Related Information

• Primary Sponsor: Tomioka Yuusuke