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
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
- Conditions
- HyperkalaemiaHeart Failure With Reduced Ejection Fraction
- Interventions
- First Posted Date
- 2020-12-21
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 366
- Registration Number
- NCT04676646
- Locations
- 🇬🇧
Research Site, Sheffield, United Kingdom
Comparison of Potassium Binders in the ER
- Conditions
- Acute HyperkalemiaOral Potassium Binders
- Interventions
- Drug: Sodium Polystyrene Sulfonate Oral Suspension [SPS]
- First Posted Date
- 2020-10-14
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- University of California, Irvine
- Target Recruit Count
- 120
- Registration Number
- NCT04585542
- Locations
- 🇺🇸
University of California, Irvine Medical Center, Orange, California, United States
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
- Conditions
- Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
- Interventions
- Drug: Sodium Polystyrene Sulphonate 15g/60 mL water
- First Posted Date
- 2020-09-28
- Last Posted Date
- 2023-11-07
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 147
- Registration Number
- NCT04566653
- Locations
- 🇸🇪
Research Site, Stockholm, Sweden
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
- Conditions
- Hyperkalemia
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-01-03
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 134
- Registration Number
- NCT04217590
- Locations
- 🇨🇳
Research Site, Yinchuan, China
The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia
- Conditions
- Type 2 Diabetes Mellitus With Kidney Complications
- Interventions
- Drug: Placebos
- First Posted Date
- 2019-08-21
- Last Posted Date
- 2019-10-16
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Target Recruit Count
- 20
- Registration Number
- NCT04063930
- Locations
- 🇩🇰
Steno Diabetes Center Copenhagen, Gentofte, Denmark
Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
- Conditions
- Heart Failure
- Interventions
- Drug: Placebo
- First Posted Date
- 2018-05-22
- Last Posted Date
- 2021-06-15
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 182
- Registration Number
- NCT03532009
- Locations
- 🇸🇰
Research Site, Svidnik, Slovakia
Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
- First Posted Date
- 2014-06-13
- Last Posted Date
- 2018-06-27
- Lead Sponsor
- ZS Pharma, Inc.
- Target Recruit Count
- 751
- Registration Number
- NCT02163499
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
- First Posted Date
- 2014-04-08
- Last Posted Date
- 2018-08-15
- Lead Sponsor
- ZS Pharma, Inc.
- Target Recruit Count
- 123
- Registration Number
- NCT02107092
Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
- Conditions
- Hyperkalemia
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-03-14
- Last Posted Date
- 2018-12-07
- Lead Sponsor
- ZS Pharma, Inc.
- Target Recruit Count
- 258
- Registration Number
- NCT02088073
Drug Development Updates
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