A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
Summary
To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).
Timeline
- Start
- 2017-03-03
- Primary completion
- 2018-02-14
- Completion
- 2018-02-14
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Sodium Zirconium Cyclosilicate (ZS) 10g: 4.381 (4.265 to 4.501) mmol/L NCT02875834 ↗
registry analysis (other test); Sodium Zirconium Cyclosilicate (ZS) 10g vs Placebo; p <0.001; Mean Difference (Final Values) 0.823 (95% CI 0.797 to 0.850); Mixed Models Analysis NCT02875834 ↗
registry analysis (other test); Sodium Zirconium Cyclosilicate (ZS) 5g vs Placebo; p <0.001; Mean Difference (Final Values) 0.904 (95% CI 0.876 to 0.933); Mixed Models Analysis NCT02875834 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Zirconium Cyclosilicate | Other / unclassified | 5 g | Oral |
| Subject | Sodium Zirconium Cyclosilicate | Other / unclassified | 10 g | Oral |
Indications
No indication recorded.