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

Ardelyx

Status and phase: Completed; Phase 2

Conditions: Hyperkalemia

Treatments: Drug: Placebo; Drug: RDX013

Study type: Interventional

Funder types: Industry

Identifiers

NCT04780841

RDX013-201

Details and patient eligibility

About

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

Enrollment: 109 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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109 participants in 6 patient groups, including a placebo group

RDX013 Cohort 1

Experimental group

Description:

RDX013 low dose oral dosage, twice daily

Treatment:

Drug: RDX013

RDX013 Cohort 2

Experimental group

Description:

RDX013 low, mid dose oral dosage, twice daily

Treatment:

Drug: RDX013

RDX013 Cohort 3

Experimental group

Description:

RDX013 high, mid dose oral dosage, twice daily

Treatment:

Drug: RDX013

RDX013 Cohort 4

Experimental group

Description:

RDX013 high dose oral dosage, twice daily

Treatment:

Drug: RDX013

RDX013 Part B

Experimental group

Description:

RDX013 dose from Part A oral dosage, twice daily

Treatment:

Drug: RDX013

Placebo Part B

Placebo Comparator group

Description:

oral dosage, twice daily

Treatment:

Drug: Placebo