Skip to main content
OpenTrials
Completed

NCT Number: NCT04780841

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Horizon Research Group LLC, Coral Gables, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RDX013

Drug

RDX013 is an experimental drug that is a potassium secretagogue

Placebo

Drug

Placebo treatment that looks identical to experimental treatment

Primary outcomes

  1. Change in serum potassium; Part A

    Time frame: 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.

  2. Change in serum potassium; Part B

    Time frame: 4 weeks

    To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment.

Secondary outcomes

  1. Exporatory Objective; time to serum potassium normalization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Registry information

Official study 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

Acronym: Redukx

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.