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

Phase 3

Completed

• Conditions: Hyperkalemia
• Interventions: Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes; Drug: Placebo

• Registration Number: NCT04955678
• Lead Sponsor: Zeria Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-09
• Study Start: 2021-08-03
• Status Verified: 2022-10
• Primary Completion: 2022-12-26
• Study Completion: 2023-03-13
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZG-801	Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in serum potassium value at Double-blind period week4	Double-blind period baseline to Double-blind period week4

Secondary Outcome Measures

Name	Time	Method
Time to First Non-maintenance of Serum Potassium Value in Double-blind Period	Double-blind period baseline to Double-blind period week4
Change in Serum Potassium Value	Run-in period baseline to Run-in period week 5
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
RAASi dose sustaining proportion	Double-blind period baseline to Double-blind period week4

Trial Locations

Locations (1)

Zeria Investigative Site; 🇯🇵 Hitachinaka, Ibaraki, Japan