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

Primary Purpose

Hyperkalemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Hyperkalemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Zeria Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZG-801

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in serum potassium value at Double-blind period week4

Secondary Outcome Measures

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

Time to First Non-maintenance of Serum Potassium Value in Double-blind Period

RAASi dose sustaining proportion

Change in Serum Potassium Value

Full Information

NCT ID

NCT04955678

First Posted

July 1, 2021

Last Updated

April 18, 2023

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT04955678

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 3, 2021 (Actual)

Primary Completion Date

December 26, 2022 (Actual)

Study Completion Date

March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperkalemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ZG-801

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.

Primary Outcome Measure Information:

Title

Change in serum potassium value at Double-blind period week4

Time Frame

Double-blind period baseline to Double-blind period week4

Secondary Outcome Measure Information:

Title

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

Time Frame

Double-blind period baseline to Double-blind period week4

Title

Time to First Non-maintenance of Serum Potassium Value in Double-blind Period

Time Frame

Double-blind period baseline to Double-blind period week4

Title

RAASi dose sustaining proportion

Time Frame

Double-blind period baseline to Double-blind period week4

Title

Change in Serum Potassium Value

Time Frame

Run-in period baseline to Run-in period week 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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. Sodium polystyrene sulfonate Calcium polystyrene sulfonate Sodium zirconium cyclosilicate hydrate 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yusuke Tomioka

Organizational Affiliation

Zeria Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

Zeria Investigative Site

City

Hitachinaka

State/Province

Ibaraki

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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