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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
109
Horizon Research Group LLC
Coral Gables, Florida, United States
Panax Clinical Research LLC
Miami Lakes, Florida, United States
South Florida Research Phase I-IV; Inc.
Miami Springs, Florida, United States
NW Louisiana Nephrology Assoc
Shreveport, Louisiana, United States
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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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Clinical Research Consultants
Kansas City, Missouri, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, United States