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

Sponsor

Ardelyx (Industry)

Overall Status

Completed

CT.gov ID

NCT04780841

Collaborator

(none)

109

Enrollment

Locations

Arms

13.7

Actual Duration (Months)

18.2

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia	Drug: RDX013 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

In Part A, treatment arms will be dosed based on the results from the previous arm. For Part B, one treatment arm from Part A will be selectedIn Part A, treatment arms will be dosed based on the results from the previous arm. For Part B, one treatment arm from Part A will be selected

Masking:

Single (Participant)

Masking Description:

This is a two part study; Part A is open label and Part B is blinded to study participants (all drug labels for treatment arm and placebo will be identical)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 11, 2021

Actual Primary Completion Date :

Dec 28, 2021

Actual Study Completion Date :

Mar 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RDX013 Cohort 1 RDX013 low dose oral dosage, twice daily	Drug: RDX013 RDX013 is an experimental drug that is a potassium secretagogue
Experimental: RDX013 Cohort 2 RDX013 low, mid dose oral dosage, twice daily	Drug: RDX013 RDX013 is an experimental drug that is a potassium secretagogue
Experimental: RDX013 Cohort 3 RDX013 high, mid dose oral dosage, twice daily	Drug: RDX013 RDX013 is an experimental drug that is a potassium secretagogue
Experimental: RDX013 Cohort 4 RDX013 high dose oral dosage, twice daily	Drug: RDX013 RDX013 is an experimental drug that is a potassium secretagogue
Experimental: RDX013 Part B RDX013 dose from Part A oral dosage, twice daily	Drug: RDX013 RDX013 is an experimental drug that is a potassium secretagogue
Placebo Comparator: Placebo Part B oral dosage, twice daily	Drug: Placebo Placebo treatment that looks identical to experimental treatment

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Clinical Research Consultants	Kansas City	Missouri	United States	64111
6	Mountain Kidney & Hypertension Associates	Asheville	North Carolina	United States	28801

Sponsors and Collaborators

Ardelyx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ardelyx

ClinicalTrials.gov Identifier:

NCT04780841

Other Study ID Numbers:

RDX013-201

First Posted:

Mar 4, 2021

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperkalemia

Study Results

No Results Posted as of May 4, 2022