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Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03799926
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: patiromer Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stratum 1: 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
 Drug: patiromer
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)
Experimental: Stratum 1: 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
 Drug: patiromer
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)
Experimental: Stratum 1: placebo of 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
 Drug: placebo
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)
Experimental: Stratum 1: placebo of 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
 Drug: placebo
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)
Experimental: Stratum 2: 8.4 g patiromer
Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
 Drug: patiromer
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)
Experimental: Stratum 2: 16.8 g patiromer
Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
 Drug: patiromer
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)
Experimental: Stratum 3: 8.4 g patiromer
Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
 Drug: patiromer
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)
Experimental: Stratum 3: 16.8 g patiromer
Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
 Drug: patiromer
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change in serum potassium 4 weeks after the start of administration in each group of starting dose [ Time Frame: Baseline to week 4 ]
  2. 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 ]
  3. Incidence of adverse events [ Time Frame: Over 52-week study period ]
  4. Incidence of adverse drug reactions [ Time Frame: Over 52-week study period ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799926


Locations
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Japan
Zeria Investigative Sites
Kanagawa, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
More Information
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Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT03799926    
Other Study ID Numbers: ZG-801-01
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases