A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia (Redukx)
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia (Redukx)
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 levelsµ
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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: Single (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)
Primary Purpose: Treatment
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
Actual Study Start Date: January 11, 2021
Actual Primary Completion Date: December 28, 2021
Estimated Study Completion Date: March 30, 2022
Arm:
- Experimental: RDX013 Cohort 1
- Experimental: RDX013 Cohort 2
- Experimental: RDX013 Cohort 3
- Experimental: RDX013 Cohort 4
- Experimental: RDX013 Part B
- Placebo Comparator: Placebo Part B
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 120 |
| Actual Study start date | 11 January 2021 |
| Estimated Study Completion Date | 30 March 2022 |