Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04780841 | A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia | PHASE2 | COMPLETED | 109 | — | — | Jan 11, 2021 | Mar 3, 2022 | May 4, 2022 | 6 | United States |
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 |