Hyperkalemia
Conditions
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.
Interventions
DRUGCalcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
ZG-801 is powder for suspension. In Run-in period, ZG-801 is taken once a day for 4 or 5 weeks. In Double-blind period, ZG-801 is taken once a day for 4 weeks.
DRUGPlacebo
Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum potassium value at Double-blind period week4 | Double-blind period baseline to Double-blind period week4 |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of serum potassium value within 3.5 mEq/L to < 5.1 mEq/L or within 3.5 mEq/L to <5.5 mEq/L in Double-blind Period | Double-blind period baseline to Double-blind period week4 |
| Time to First Non-maintenance of Serum Potassium Value in Double-blind Period | Double-blind period baseline to Double-blind period week4 |
| RAASi dose sustaining proportion | Double-blind period baseline to Double-blind period week4 |
| Change in Serum Potassium Value | Run-in period baseline to Run-in period week 5 |
Countries
Japan
Outcome results
None listed