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Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Primary Purpose

Hyperkalemia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

patiromer

placebo

patiromer

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:

Males and females ages 18 - 80
Informed consent given
Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)

Exclusion Criteria:

Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Sites / Locations

Zeria Investigative Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Stratum 1: 8.4 g patiromer

Stratum 1: 16.8 g patiromer

Stratum 1: placebo of 8.4 g patiromer

Stratum 1: placebo of 16.8 g patiromer

Stratum 2: 8.4 g patiromer

Stratum 2: 16.8 g patiromer

Stratum 3: 8.4 g patiromer

Stratum 3: 16.8 g patiromer

Arm Description

Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline

Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline

Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline

Outcomes

Primary Outcome Measures

Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose

Secondary Outcome Measures

Change in serum potassium 4 weeks after the start of administration in each group of starting dose

Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose

Incidence of adverse events

Incidence of adverse drug reactions

Full Information

NCT ID

NCT03799926

First Posted

January 8, 2019

Last Updated

March 23, 2021

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT03799926

Brief Title

Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Official Title

ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 18, 2019 (Actual)

Primary Completion Date

November 6, 2019 (Actual)

Study Completion Date

February 2, 2021 (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

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients. To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stratum 1: 8.4 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline

Arm Title

Stratum 1: 16.8 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline

Arm Title

Stratum 1: placebo of 8.4 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline

Arm Title

Stratum 1: placebo of 16.8 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline

Arm Title

Stratum 2: 8.4 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline

Arm Title

Stratum 2: 16.8 g patiromer

Arm Type

Experimental

Arm Description

Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline

Arm Title

Stratum 3: 8.4 g patiromer

Arm Type

Experimental

Arm Description

Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline

Arm Title

Stratum 3: 16.8 g patiromer

Arm Type

Experimental

Arm Description

Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)

Intervention Type

Drug

Intervention Name(s)

patiromer

Intervention Description

Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)

Primary Outcome Measure Information:

Title

Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose

Time Frame

Baseline to week 1

Secondary Outcome Measure Information:

Title

Change in serum potassium 4 weeks after the start of administration in each group of starting dose

Time Frame

Baseline to week 4

Title

Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose

Time Frame

Week 4

Title

Incidence of adverse events

Time Frame

Over 52-week study period

Title

Incidence of adverse drug reactions

Time Frame

Over 52-week study period

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: Males and females ages 18 - 80 Informed consent given Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients) Exclusion Criteria: Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Facility Information:

Facility Name

Zeria Investigative Sites

City

Kanagawa

Country

Japan

12. IPD Sharing Statement

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Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

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