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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2022-03-03

Brief Summary

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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

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Detailed Description

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Conditions

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Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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)

Study Groups

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RDX013 Cohort 1

RDX013 low dose oral dosage, twice daily

Group Type EXPERIMENTAL

RDX013

Intervention Type DRUG

RDX013 is an experimental drug that is a potassium secretagogue

RDX013 Cohort 2

RDX013 low, mid dose oral dosage, twice daily

Group Type EXPERIMENTAL

RDX013

Intervention Type DRUG

RDX013 is an experimental drug that is a potassium secretagogue

RDX013 Cohort 3

RDX013 high, mid dose oral dosage, twice daily

Group Type EXPERIMENTAL

RDX013

Intervention Type DRUG

RDX013 is an experimental drug that is a potassium secretagogue

RDX013 Cohort 4

RDX013 high dose oral dosage, twice daily

Group Type EXPERIMENTAL

RDX013

Intervention Type DRUG

RDX013 is an experimental drug that is a potassium secretagogue

RDX013 Part B

RDX013 dose from Part A oral dosage, twice daily

Group Type EXPERIMENTAL

RDX013

Intervention Type DRUG

RDX013 is an experimental drug that is a potassium secretagogue

Placebo Part B

oral dosage, twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo treatment that looks identical to experimental treatment

Interventions

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RDX013

RDX013 is an experimental drug that is a potassium secretagogue

Intervention Type DRUG

Placebo

Placebo treatment that looks identical to experimental treatment

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No