NCT04780841

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	RDX013	RDX013 is an experimental drug that is a potassium secretagogue
DRUG	Placebo	Placebo treatment that looks identical to experimental treatment

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-12-28
• Completion: 2022-03-03
• First posted: 2021-03-04
• Last updated: 2022-05-04

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study