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

Zeria Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Hyperkalemia

Treatments

Drug: Placebo

Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes

Study type

Interventional

Funder types

Industry

Identifiers

NCT04955678

ZG-801-02

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Main Exclusion Criteria:

Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
Patients with poorly controlled blood pressure
Patients with heart failure in New York Heart Association Class IV
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
Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
1. Sodium polystyrene sulfonate
2. Calcium polystyrene sulfonate
3. Sodium zirconium cyclosilicate hydrate
4. Potassium supplement
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).
Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)