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The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDX013 Cohort 1 | Experimental | RDX013 low dose oral dosage, twice daily |
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| RDX013 Cohort 2 | Experimental | RDX013 low, mid dose oral dosage, twice daily |
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| RDX013 Cohort 3 | Experimental | RDX013 high, mid dose oral dosage, twice daily |
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| RDX013 Cohort 4 | Experimental | RDX013 high dose oral dosage, twice daily |
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| RDX013 Part B | Experimental | RDX013 dose from Part A oral dosage, twice daily |
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| Placebo Part B | Placebo Comparator | oral dosage, twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDX013 | Drug | RDX013 is an experimental drug that is a potassium secretagogue |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium; Part A | To evaluate the change of serum potassium from baseline to the end of treatment with different doses of RDX013 to identify the optimal dose for further evaluation in Part B of the study. | 1 week |
| Change in serum potassium; Part B | To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exporatory Objective; time to serum potassium normalization | To evaluate the time to initial normalization of serum potassium level (≥3.5 to ≤5.0 mmol/L) during the initial 24 hours of treatment. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Research Group LLC | Coral Gables | Florida | 33134 | United States | ||
| Panax Clinical Research LLC |
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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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In Part A, treatment arms will be dosed based on the results from the previous arm. For Part B, one treatment arm from Part A will be selected
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This is a two part study; Part A is open label and Part B is blinded to study participants (all drug labels for treatment arm and placebo will be identical)
| Placebo | Drug | Placebo treatment that looks identical to experimental treatment |
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| Miami Lakes |
| Florida |
| 33014 |
| United States |
| South Florida Research Phase I-IV; Inc. | Miami Springs | Florida | 33166 | United States |
| NW Louisiana Nephrology Assoc | Shreveport | Louisiana | 71101 | United States |
| Clinical Research Consultants | Kansas City | Missouri | 64111 | United States |
| Mountain Kidney & Hypertension Associates | Asheville | North Carolina | 28801 | United States |