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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1: 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
|
| Stratum 1: 16.8 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
|
| Stratum 1: placebo of 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
|
| Stratum 1: placebo of 16.8 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
|
| Stratum 2: 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline |
|
| Stratum 2: 16.8 g patiromer | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patiromer | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose | Baseline to week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium 4 weeks after the start of administration in each group of starting dose | Baseline to week 4 | |
| Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeria Investigative Sites | Kanagawa | Japan |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C568789 | patiromer |
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Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline |
|
| Stratum 3: 8.4 g patiromer | Experimental | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
|
| Stratum 3: 16.8 g patiromer | Experimental | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
|
| patiromer | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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) |
|
| Week 4 |
| Incidence of adverse events | Over 52-week study period |
| Incidence of adverse drug reactions | Over 52-week study period |