Hyperkalemia
Conditions
Brief summary
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
Interventions
DRUGRDX013
RDX013 is an experimental drug that is a potassium secretagogue
DRUGPlacebo
Placebo treatment that looks identical to experimental treatment
Sponsors
Ardelyx
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 18 to 85 years, inclusive 2. Serum potassium value 5.1 to \<6.5 mmol/L 3. Chronic kidney disease with eGFR ≥20 to \<60 mL/min/1.73m2 4. Able to understand and comply with the protocol 5. Willing and able to sign informed consent
Exclusion criteria
1. Pseudo-hyperkalemia signs and symptoms 2. Treatment with potassium-lowering drugs within 7 days prior to enrollment/randomization 3. Treatment with glucocorticoids 4. Uncontrolled Type 2 diabetes, defined as most recent historical HbA1c \> 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months 5. Diabetic ketoacidosis 6. Severe heart failure, defined as NYHA (New York Heart Association) Class IV or hospitalization to treat heart failure in previous 3 months 7. History of bowel obstruction, severe gastrointestinal disorders, or major gastrointestinal surgery (e.g., large bowel resection) 8. Females who are pregnant, lactating, or not willing to use appropriate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum potassium; Part A | 1 week | 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. |
| Change in serum potassium; Part B | 4 weeks | To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exporatory Objective; time to serum potassium normalization | 4 weeks | 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. |
Countries
United States
Outcome results
None listed