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

Primary Purpose

Hyperkalemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RDX013
Placebo
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Horizon Research Group LLC
  • Panax Clinical Research LLC
  • South Florida Research Phase I-IV; Inc.
  • NW Louisiana Nephrology Assoc
  • Clinical Research Consultants
  • Mountain Kidney & Hypertension Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

RDX013 Cohort 1

RDX013 Cohort 2

RDX013 Cohort 3

RDX013 Cohort 4

RDX013 Part B

Placebo Part B

Arm Description

RDX013 low dose oral dosage, twice daily

RDX013 low, mid dose oral dosage, twice daily

RDX013 high, mid dose oral dosage, twice daily

RDX013 high dose oral dosage, twice daily

RDX013 dose from Part A oral dosage, twice daily

oral dosage, twice daily

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 26, 2021
Last Updated
May 3, 2022
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT04780841
Brief Title
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
March 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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 selected
Masking
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)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDX013 Cohort 1
Arm Type
Experimental
Arm Description
RDX013 low dose oral dosage, twice daily
Arm Title
RDX013 Cohort 2
Arm Type
Experimental
Arm Description
RDX013 low, mid dose oral dosage, twice daily
Arm Title
RDX013 Cohort 3
Arm Type
Experimental
Arm Description
RDX013 high, mid dose oral dosage, twice daily
Arm Title
RDX013 Cohort 4
Arm Type
Experimental
Arm Description
RDX013 high dose oral dosage, twice daily
Arm Title
RDX013 Part B
Arm Type
Experimental
Arm Description
RDX013 dose from Part A oral dosage, twice daily
Arm Title
Placebo Part B
Arm Type
Placebo Comparator
Arm Description
oral dosage, twice daily
Intervention Type
Drug
Intervention Name(s)
RDX013
Intervention Description
RDX013 is an experimental drug that is a potassium secretagogue
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment that looks identical to experimental treatment
Primary Outcome Measure Information:
Title
Change in serum potassium; Part A
Description
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.
Time Frame
1 week
Title
Change in serum potassium; Part B
Description
To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Exporatory Objective; time to serum potassium normalization
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Horizon Research Group LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Panax Clinical Research LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
South Florida Research Phase I-IV; Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
NW Louisiana Nephrology Assoc
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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