Clinical Trials Logo
  1. Home
  2. Hyperkalemia
  3. NCT04217590

Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects — DIALIZE China  

Hyperkalemia Clinical Trial

Official title:
A Phase 3b, Multicentre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study to determine the safety and efficacy of SZC in ESRD subjects with hyperkalaemia and on stable haemodialysis. This study consists of a screening period, an 8-week randomized treatment period, and a follow-up period. Approximately 134 stable haemodialysis subjects with persistent pre-dialysis hyperkalaemia will be enrolled in the study across research sites in China. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04217590
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date November 16, 2020
Completion date January 3, 2022
View Details
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
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
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
Completed NCT03528681 - A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. Phase 3
Completed NCT02107092 - Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. Phase 3