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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx

Criteria

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