Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Sodium zirconium cyclosilicate

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    13 result(s) found for: Sodium zirconium cyclosilicate. Displaying page 1 of 1.
    EudraCT Number: 2018-000175-33 Sponsor Protocol Number: D9484C00001 Start Date*: 2018-06-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase II, Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicentre, Three Month Duration Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy with Sodium Zirconium ...
    Medical condition: Heart Failure; Hyperkalaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) SK (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001331-48 Sponsor Protocol Number: D9481C00001 Start Date*: 2019-03-18
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for t...
    Medical condition: Hyperkalaemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10020647 Hyperkalemia LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Trial now transitioned) RO (Trial now transitioned) DE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003527-14 Sponsor Protocol Number: D9480C00023 Start Date*: 2021-12-17
    Sponsor Name:ASTRAZENECA AB
    Full Title: An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) after Discharge in Participants with Chronic Kidney Disease treated for Hyperkalaemia
    Medical condition: Patients with Chronic Kidney Disease treated for Hyperkalaemia whilst in hospital, who are normokalemic and established on maintenance dose of SZC at discharge.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10020646 Hyperkalaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Ongoing) FR (Completed) NL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005561-14 Sponsor Protocol Number: D9487C00001 Start Date*: 2021-07-15
    Sponsor Name:AstraZeneca AB
    Full Title: An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic...
    Medical condition: Pre-dialysis hyperkalemia in patients with end stage renal disease (ESRD) on chronic hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10020646 Hyperkalaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) CZ (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended) SK (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003955-50 Sponsor Protocol Number: D9480C00005 Start Date*: 2017-12-21
    Sponsor Name:AstraZeneca, AB
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
    Medical condition: Hyperkalemia requiring urgent therapy (serum potassium more than or equal to 5.8mmol/L).
    Disease: Version SOC Term Classification Code Term Level
    20.1 10027433 - Metabolism and nutrition disorders 10020646 Hyperkalaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000695-38 Sponsor Protocol Number: 2020-000695-38 Start Date*: 2020-06-12
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: Healthy diet rich in potassium containing fruits, vegetables and nuts to chronic kidney disease patients thought the use of sodium zirconium cyclosilicate: A Feasibility Study
    Medical condition: Chronic kidney disease, stages 4 and 5 of the disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-003312-27 Sponsor Protocol Number: D9480C00018 Start Date*: 2021-03-02
    Sponsor Name:AstraZeneca AB
    Full Title: Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failur...
    Medical condition: Hyperkalemia in Patients with Symptomatic Heart Failure.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10020646 Hyperkalaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-003029-14 Sponsor Protocol Number: D9480C00006 Start Date*: 2018-02-09
    Sponsor Name:AstraZeneca AB
    Full Title: A phase 3b, multicenter, prospective, randomized, double blind, placebocontrolled study to reduce incidence of pre-dialysis hyperkalemia with Sodium Zirconium Cyclosilicate (DIALIZE)
    Medical condition: Hyperkalemia among patients on stable hemodialysis (pre-dialysis serum K >5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10027433 - Metabolism and nutrition disorders 10020646 Hyperkalaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-001911-96 Sponsor Protocol Number: D9488C00001 Start Date*: 2021-11-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants wit...
    Medical condition: Chronic kidney disease (CKD) with hyperkalaemia or at risk of hyperkalaemia
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004857 10076410 Chronic kidney disease stage 3 LLT
    23.1 100000004857 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) IT (Prematurely Ended) ES (Ongoing) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000595-42 Sponsor Protocol Number: ESR-18-13834 Start Date*: 2019-07-08
    Sponsor Name:Steno Diabetes Center Copenhagen
    Full Title: A randomized, double-blind, placebo controlled, parallel, multicentre study of the effects of 12-weeks of sodium zirconium cyclosilicate (Lokelma) on albuminuria (UACR) in patients with diabetes an...
    Medical condition: Treatment for proteinuria in type 1 or type 2 diabetes with hyperkalemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003229-47 Sponsor Protocol Number: KEEP-ON Start Date*: 2022-01-12
    Sponsor Name:Instituto de Investigación Sanitaria INCLIVA
    Full Title: Phase III, multicenter, open-label, randomized clinical trial to evaluate efficacy of Sodium Zirconium Cyclosilicate (Lokelma) compared to standard of care to manage hyperkalemia in patients with c...
    Medical condition: Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10020647 Hyperkalemia LLT
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    20.0 100000004849 10019285 Heart failure, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005176-35 Sponsor Protocol Number: ESR-19-20262 Start Date*: 2021-01-14
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure (OPRA-HF)
    Medical condition: Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004555-31 Sponsor Protocol Number: ZS-005 Start Date*: 2015-04-17
    Sponsor Name:ZS Pharma Inc
    Full Title: A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia
    Medical condition: Hyperkalemia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10020647 Hyperkalemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed) RO (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 20 12:56:15 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA