Clinical trial NCT04955678: A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
Official title: ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperkalemia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in serum potassium value at Double-blind period week4
timeFrame: Double-blind period baseline to Double-blind period week4
Secondary outcomes:
measure: 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
timeFrame: Double-blind period baseline to Double-blind period week4
measure: Time to First Non-maintenance of Serum Potassium Value in Double-blind Period
timeFrame: Double-blind period baseline to Double-blind period week4
measure: RAASi dose sustaining proportion
timeFrame: Double-blind period baseline to Double-blind period week4
measure: Change in Serum Potassium Value
timeFrame: Run-in period baseline to Run-in period week 5
Other outcomes:
Locations:
city: Hitachinaka
country: Japan
facility: Zeria Investigative Site
state: Ibaraki
Study officials:
affiliation: Zeria Pharmaceutical
name: Yusuke Tomioka
role: STUDY_DIRECTOR
References: