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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

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

Key facts

Study ID

NCT04780841

Run by

Ardelyx

People needed

109

Starts

2021-01-11

Expected to finish

2022-03-03

Last updated by the study team

2022-05-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Clinical Research Consultants — Kansas City, Missouri, United States
• Mountain Kidney & Hypertension Associates — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.