AstraZeneca: Hyperkalemia trials

The registry lists 38 Hyperkalemia studies with AstraZeneca as lead sponsor. 1 are open to participants now and 22 have results posted.

Phase 1 2Phase 2 4Phase 3 14Phase 4 4No phase 15(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With HyperkalaemiaRecruitingNCT03813407Phase 3
• Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge StudyCompletedNCT05347693Phase 4Results posted
• 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 HyperkalaemiaTerminatedNCT05056727Phase 3Results posted
• Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With HyperkalaemiaTerminatedNCT04997161Phase 4Results posted
• Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)TerminatedNCT04847232Phase 3Results posted
• Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy SubjectsCompletedNCT04788641Phase 1Results posted
• Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney DiseaseTerminatedNCT04727528Phase 3Results posted
• Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving SpironolactoneCompletedNCT04676646Phase 4Results posted
• Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese SubjectsCompletedNCT04217590Phase 3Results posted
• Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart FailureTerminatedNCT03532009Phase 2Results posted
• A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.CompletedNCT03528681Phase 3Results posted
• A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8CompletedNCT03337477Phase 2Results posted
• A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.CompletedNCT03303521Phase 3Results posted
• Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With HyperkalemiaCompletedNCT03172702Phase 3Results posted
• ZS Ph2/3 Dose-response Study in JapanCompletedNCT03127644Phase 2/3Results posted
• A Study to Investigate the Safety and Efficacy of ZS in Patients With HyperkalemiaCompletedNCT02875834Phase 3Results posted
• POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational StudyCompletedNCT02609841Results posted
• Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 MonthsCompletedNCT02163499Phase 3Results posted
• Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.CompletedNCT02107092Phase 3Results posted
• Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.CompletedNCT02088073Phase 3Results posted
• Safety and Efficacy of Sodium Polystyrene Sulfonate in HyperkalemiaTerminatedNCT01866709Phase 4Results posted
• Safety & Efficacy of Zirconium Silicate in Mild to Moderate HyperkalemiaCompletedNCT01737697Phase 3Results posted
• Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild HyperkalemiaCompletedNCT01493024Phase 2Results posted
• Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in BrazilCompletedNCT07370194
• Hyperkalemia Quality Improvement Program (HK-QIP) StudyActive, not recruitingNCT06884267Not applicable
• VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in SpainCompletedNCT06635499
• A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in GreeceCompletedNCT06185660
• Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal InsufficiencyCompletedNCT05462119
• Tracking Treatment Pathways in Adult Patients With Hyperkalemia.CompletedNCT05408039
• An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart FailureCompletedNCT05297409
• A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in ChinaCompletedNCT05271266
• Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium LevelsCompletedNCT05184998
• Hyperkalaemia Prevalence, Recurrence and Treatment in HaemodialysisCompletedNCT04799067
• Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and HyperkalaemiaCompletedNCT04566653
• Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot StudyCompletedNCT04466969
• Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)CompletedNCT03657875
• A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)CompletedNCT03283267Phase 1
• REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational StudyCompletedNCT02607085