Clinical Trials Logo

Clinical Trial 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 24 or 48 hours of initial ZS therapy (10g TID).


Clinical Trial Description

This study will be conducted in approximately 35 centers in China. Before patients are randomized to the double-blind phase, they will receive open-label ZS for 24 or 48 hours during the initial phase. It is expected that approximately 490 patients will need to be enrolled, to have approximately 280 patients entered into the open-label initial phase resulting in 250 patients being randomized in the 28-day treatment study phase. Enrolment will be stopped when 250 patients have been initiated with the 28-day randomized treatment study phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03528681
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date May 6, 2021
Completion date September 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT03172702 - Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia Phase 3
Terminated NCT05056727 - A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia Phase 3
Recruiting NCT05766839 - Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age Phase 2
Completed NCT02609841 - POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study N/A
Recruiting NCT06277128 - A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia. Phase 2
Recruiting NCT04789239 - OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure Phase 2
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Terminated NCT04443608 - Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management Phase 4
Completed NCT02607085 - REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study N/A
Completed NCT03283267 - A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS) Phase 1
Recruiting NCT06036823 - 5 Versus 10 Units of Insulin in Hyperkalemia Management Phase 4
Recruiting NCT05173584 - Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects. Phase 4
Completed NCT05184998 - Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
Completed NCT01737697 - Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia Phase 3
Completed NCT01493024 - Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia Phase 2
Completed NCT04207203 - Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study N/A
Completed NCT05382988 - Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy Phase 3
Completed NCT04217590 - Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects Phase 3
Recruiting NCT03096561 - Measurement of Serum Potassium Rate During Accidental Hypothermia. N/A
Completed NCT03326583 - The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia Phase 2