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

ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -

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.

Study Overview

• Status: Completed
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Ibaraki
    • Hitachinaka, Ibaraki, Japan
      • Zeria Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.
Experimental: ZG-801	Drug: Calcium, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum potassium value at Double-blind period week4	Double-blind period baseline to Double-blind period week4

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical
• Investigators: Study Director: Yusuke Tomioka, Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): December 26, 2022
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia; Physiological Effects of Drugs; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Cathartics; Calcium; Sorbitol
• Other Study ID Numbers: ZG-801-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No