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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2023-03-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZG-801

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No