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

Phase 2

Completed

• Conditions: Hyperkalemia
• Interventions: Drug: RDX013; Drug: Placebo

• Registration Number: NCT04780841
• Lead Sponsor: Ardelyx

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2021-12-28
• Study Completion: 2022-03-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RDX013 Cohort 1	RDX013	RDX013 low dose oral dosage, twice daily
Placebo Part B	Placebo	oral dosage, twice daily
RDX013 Part B	RDX013	RDX013 dose from Part A oral dosage, twice daily
RDX013 Cohort 2	RDX013	RDX013 low, mid dose oral dosage, twice daily
RDX013 Cohort 4	RDX013	RDX013 high dose oral dosage, twice daily
RDX013 Cohort 3	RDX013	RDX013 high, mid dose oral dosage, twice daily

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Horizon Research Group LLC; 🇺🇸 Coral Gables, Florida, United States

Panax Clinical Research LLC; 🇺🇸 Miami Lakes, Florida, United States

NW Louisiana Nephrology Assoc; 🇺🇸 Shreveport, Louisiana, United States

Mountain Kidney & Hypertension Associates; 🇺🇸 Asheville, North Carolina, United States

Clinical Research Consultants; 🇺🇸 Kansas City, Missouri, United States

South Florida Research Phase I-IV; Inc.; 🇺🇸 Miami Springs, Florida, United States