Approval Probability
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RDX013 · 1 trial · 1 indication
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.
To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment.
| Arm | Type | Description |
|---|---|---|
| RDX013 Cohort 1 | EXPERIMENTAL | RDX013 low dose oral dosage, twice daily |
| RDX013 Cohort 2 | EXPERIMENTAL | RDX013 low, mid dose oral dosage, twice daily |
| RDX013 Cohort 3 | EXPERIMENTAL | RDX013 high, mid dose oral dosage, twice daily |
| RDX013 Cohort 4 | EXPERIMENTAL | RDX013 high dose oral dosage, twice daily |
| RDX013 Part B | EXPERIMENTAL | RDX013 dose from Part A oral dosage, twice daily |
| Placebo Part B | PLACEBO_COMPARATOR | oral dosage, twice daily |
| Name | Type | Description |
|---|---|---|
| RDX013 | DRUG | RDX013 is an experimental drug that is a potassium secretagogue |
| Placebo | DRUG | Placebo treatment that looks identical to experimental treatment |
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. ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 3 | PHASE3 | Zirconium Cyclosilicate Reduced Dose Level, Zirconium Cyclosilicate Dose Level 1, Zirconium Cyclosilicate Dose During 28 Day Maintenance Phase |
RDX013 is an investigational small molecule being developed for the treatment of hyperkalemia, a condition of elevated potassium levels in the blood. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
RDX013 is being developed by Ardelyx, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARDX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for hyperkalemia.
RDX013 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in patients with hyperkalemia.
RDX013 has one completed Phase 2 clinical trial registered as NCT04780841, titled 'A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia.' The trial enrolled 109 participants in the United States and was placebo-controlled.
RDX013 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for hyperkalemia. The completed clinical trial, NCT04780841, evaluated its safety and efficacy, but regulatory approval has not been granted.