Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
NCT ID: NCT03799926
Last Updated: 2021-03-25
Study Results
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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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2019-02-18
2021-02-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stratum 1: 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
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)
Stratum 1: 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
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)
Stratum 1: placebo of 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
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)
Stratum 1: placebo of 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
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)
Stratum 2: 8.4 g patiromer
Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline
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)
Stratum 2: 16.8 g patiromer
Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline
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)
Stratum 3: 8.4 g patiromer
Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline
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)
Stratum 3: 16.8 g patiromer
Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline
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)
Interventions
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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)
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)
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)
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)
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)
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)
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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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Zeria Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Zeria Investigative Sites
Kanagawa, , Japan
Countries
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Other Identifiers
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ZG-801-01
Identifier Type: -
Identifier Source: org_study_id
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