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Potassium Binder
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia (Redukx Trial)
Phase 2
Waitlist Available
Research Sponsored by Ardelyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial is testing a medication called RDX013 to see if it can lower high potassium levels in people with chronic kidney disease. These patients often struggle with high potassium, which can be dangerous. RDX013 aims to help the body remove extra potassium from the blood.
Eligible Conditions
- Hyperkalemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in serum potassium; Part A
Change in serum potassium; Part B
Secondary study objectives
Exporatory Objective; time to serum potassium normalization
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: RDX013 Part BExperimental Treatment1 Intervention
RDX013 dose from Part A oral dosage, twice daily
Group II: RDX013 Cohort 4Experimental Treatment1 Intervention
RDX013 high dose oral dosage, twice daily
Group III: RDX013 Cohort 3Experimental Treatment1 Intervention
RDX013 high, mid dose oral dosage, twice daily
Group IV: RDX013 Cohort 2Experimental Treatment1 Intervention
RDX013 low, mid dose oral dosage, twice daily
Group V: RDX013 Cohort 1Experimental Treatment1 Intervention
RDX013 low dose oral dosage, twice daily
Group VI: Placebo Part BPlacebo Group1 Intervention
oral dosage, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RDX013
2021
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
ArdelyxLead Sponsor
29 Previous Clinical Trials
6,006 Total Patients Enrolled
1 Trials studying Hyperkalemia
60 Patients Enrolled for Hyperkalemia