Sodium zirconium cyclosilicate
- Generic Name
- Sodium zirconium cyclosilicate
- Brand Names
- Lokelma
- Drug Type
- Small Molecule
- Chemical Formula
- Na2O9Si3Zr
- CAS Number
- 17141-74-1
- Unique Ingredient Identifier
- D652ZWF066
- Background
Sodium zirconium cyclosilicate is approved as the trade product Lokelma developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent. It is administered orally and is odorless, tasteless, and stable at room temperature. Approval of the medication is supported by data from three double-blind, placebo-controlled trials and two open-label trials which showed that the onset of action was approximately 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours following administration. The treatment effect was maintained for up to 12 months.
- Indication
Sodium zirconium cyclosilicate is a potassium binder indicated for the treatment of hyperkalemia in adult patients.
- Associated Conditions
- Hyperkalemia
Keeping RAASi Treatment With Optimal Potassium Control
- First Posted Date
- 2024-08-29
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Target Recruit Count
- 78
- Registration Number
- NCT06578533
- Locations
- 🇪🇸
Hospital Universitario 12 de Octubre, Madrid, Spain
🇪🇸Hospital General Universitario Dr. Balmis, Alicante, Spain
🇪🇸Hospital Universitario Vall d'Hebrón, Barcelona, Spain
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
- Conditions
- Heart FailureChronic Kidney Diseases
- Interventions
- Drug: Standard of care treatment (RAASi therapy)
- First Posted Date
- 2024-08-29
- Last Posted Date
- 2024-10-21
- Lead Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Target Recruit Count
- 94
- Registration Number
- NCT06578078
- Locations
- 🇪🇸
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
🇪🇸Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
🇪🇸Hospital Universitario Nuestra Señora del Perpétuo Socorro, Albacete, Spain
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4
- Conditions
- HyperkalemiaDiet ModificationChronic Kidney DiseaseSodium Zirconium Cyclosilicate
- Interventions
- First Posted Date
- 2024-04-15
- Last Posted Date
- 2025-03-06
- Lead Sponsor
- Leiden University Medical Center
- Target Recruit Count
- 16
- Registration Number
- NCT06365684
- Locations
- 🇳🇱
Leiden University Medical Center, Leiden, South-Holland, Netherlands
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia
- First Posted Date
- 2022-09-10
- Last Posted Date
- 2024-06-05
- Lead Sponsor
- NephroNet, Inc.
- Target Recruit Count
- 88
- Registration Number
- NCT05535920
- Locations
- 🇺🇸
Georgia Nephrology DBA Georgia Nephrology Research Institute, Lawrenceville, Georgia, United States
🇺🇸Balboa Research, La Jolla, California, United States
🇺🇸Nephrology Associates of Northern Illinois and Indiana (NANI), Fort Wayne, Indiana, United States
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
- Conditions
- HyperkalemiaHyperparathyroidism, SecondarySodium Zirconium Cyclosilicate
- Interventions
- First Posted Date
- 2022-05-19
- Last Posted Date
- 2022-05-19
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Target Recruit Count
- 62
- Registration Number
- NCT05382988
Lokelma for RAAS Maximisation in CKD & Heart Failure.
- Conditions
- Chronic Kidney DiseasesHeart Failure With Reduced Ejection FractionHyperkalemiaACE Inhibitor Induced HyperkalaemiaMineralocorticoid Resistant Hyperkalemia
- Interventions
- First Posted Date
- 2021-08-13
- Last Posted Date
- 2023-05-18
- Lead Sponsor
- St George's, University of London
- Target Recruit Count
- 130
- Registration Number
- NCT05004363
- Locations
- 🇬🇧
St Georges, University of London, London, United Kingdom
The ORTIZ Study: Optimising RASi Therapy With SZC
- Conditions
- CKDDiabetes Mellitus, Type 2Hyperkalemia
- Interventions
- Drug: Placebo
- First Posted Date
- 2021-07-30
- Last Posted Date
- 2023-08-16
- Lead Sponsor
- Barts & The London NHS Trust
- Target Recruit Count
- 10
- Registration Number
- NCT04983979
- Locations
- 🇬🇧
Kieran Mccafferty, London, Uk, United Kingdom
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
- Conditions
- Hyperkalaemia
- Interventions
- First Posted Date
- 2021-03-09
- Last Posted Date
- 2024-04-05
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 62
- Registration Number
- NCT04788641
- Locations
- 🇩🇪
Research Site, Berlin, Germany
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
- Conditions
- Heart FailureHyperkalemia
- Interventions
- Other: Placebo
- First Posted Date
- 2021-03-09
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Michael Fu
- Target Recruit Count
- 110
- Registration Number
- NCT04789239
- Locations
- 🇸🇪
Section of Cardiology, Sahlgrenska University Hospital-Östra Hospital, Gothenburg, Västra Götalanddsregion, Sweden
🇸🇪Sahlgrenska University Hospital-Ostra Hospital, Gothenburg, Sweden
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
- Conditions
- HyperkalaemiaMetabolic AcidosisChronic Kidney Disease
- Interventions
- Drug: Placebo
- First Posted Date
- 2021-01-27
- Last Posted Date
- 2023-10-06
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 39
- Registration Number
- NCT04727528
- Locations
- 🇵🇷
Research Site, San Juan, Puerto Rico
Drug Development Updates
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