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

Hyperkalemia Clinical Trial

— Redukx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780841
• Other study ID #: RDX013-201
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: May 2022
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 3, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• RDX013
RDX013 is an experimental drug that is a potassium secretagogue
• Placebo
Placebo treatment that looks identical to experimental treatment

Locations

Country	Name	City	State
United States	Mountain Kidney & Hypertension Associates	Asheville	North Carolina
United States	Horizon Research Group LLC	Coral Gables	Florida
United States	Clinical Research Consultants	Kansas City	Missouri
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

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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