A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

Study Overview
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Brief Summary
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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

Official Title
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A Two-Part Proof-of-Concept Study: An Open-Label Dose-Ranging Phase (Part A) Followed by a Randomized, Single-Blind, Placebo-Controlled Phase (Part B) Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

Conditions
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Hyperkalemia

Intervention / Treatment
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* Drug: RDX013
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18 to 85 years, inclusive Serum potassium value 5.1 to <6.5 mmol/L Chronic kidney disease with eGFR ≥20 to <60 mL/min/1.73m2 Able to understand and comply with the protocol Willing and able to sign informed consent Exclusion Criteria: Pseudo-hyperkalemia signs and symptoms Treatment with potassium-lowering drugs within 7 days prior to enrollment/randomization Treatment with glucocorticoids Uncontrolled Type 2 diabetes, defined as most recent historical HbA1c > 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months Diabetic ketoacidosis Severe heart failure, defined as NYHA (New York Heart Association) Class IV or hospitalization to treat heart failure in previous 3 months History of bowel obstruction, severe gastrointestinal disorders, or major gastrointestinal surgery (e.g., large bowel resection) Females who are pregnant, lactating, or not willing to use appropriate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDX013 Cohort 1<br>RDX013 low dose oral dosage, twice daily | Drug: RDX013<br>* RDX013 is an experimental drug that is a potassium secretagogue<br>|
| Experimental: RDX013 Cohort 2<br>RDX013 low, mid dose oral dosage, twice daily | Drug: RDX013<br>* RDX013 is an experimental drug that is a potassium secretagogue<br>|
| Experimental: RDX013 Cohort 3<br>RDX013 high, mid dose oral dosage, twice daily | Drug: RDX013<br>* RDX013 is an experimental drug that is a potassium secretagogue<br>|
| Experimental: RDX013 Cohort 4<br>RDX013 high dose oral dosage, twice daily | Drug: RDX013<br>* RDX013 is an experimental drug that is a potassium secretagogue<br>|
| Experimental: RDX013 Part B<br>RDX013 dose from Part A oral dosage, twice daily | Drug: RDX013<br>* RDX013 is an experimental drug that is a potassium secretagogue<br>|
| Placebo Comparator: Placebo Part B<br>oral dosage, twice daily | Drug: Placebo<br>* Placebo treatment that looks identical to experimental treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |