Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
Lead Sponsor:
Ardelyx
Conditions:
Hyperkalemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2022
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04780841
Start Date
January 11 2021
End Date
March 3 2022
Last Update
May 4 2022
Active Locations (6)
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1
Horizon Research Group LLC
Coral Gables, Florida, United States, 33134
2
Panax Clinical Research LLC
Miami Lakes, Florida, United States, 33014
3
South Florida Research Phase I-IV; Inc.
Miami Springs, Florida, United States, 33166
4
NW Louisiana Nephrology Assoc
Shreveport, Louisiana, United States, 71101