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Last Updated: April 13, 2024

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CLINICAL TRIALS PROFILE FOR LOKELMA


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All Clinical Trials for Lokelma

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04063930 ↗ The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia Recruiting AstraZeneca Phase 4 2019-10-01 To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.
NCT04063930 ↗ The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia Recruiting Zealand University Hospital Phase 4 2019-10-01 To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.
NCT04063930 ↗ The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia Recruiting Steno Diabetes Center Copenhagen Phase 4 2019-10-01 To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.
NCT04585542 ↗ Comparison of Potassium Binders in the ER Recruiting University of California, Irvine Phase 4 2020-10-20 Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in patients presenting to the Emergency Room with acute hyperkalemia.
NCT04789239 ↗ OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure Recruiting AstraZeneca Phase 2 2021-09-01 Mineralocorticoid receptor antagonists (MRA) is one of cornerstones in the treatment of heart failure with reduced ejection fraction (HFrEF). However, MRA has been extremely under-used globally. The main reason for this seems to be increased risk of hyperkalemia in individuals on MRA. Theoretically, by limiting the risk of hyperkalemia it could thus be possible to optimize MRA therapy. This is studied in this randomized controlled trial in which it is investigated whethere adding a potassium-binder in combination with MRA treatment prevent hyperkalemia to a greater extent than only using MRA. The specific aim of this study is to demonstrate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) in optimizing MRA in symptomatic patients with HFrEF. A multicenter, randomized, placebo-controlled, double-blinded study in Sweden (n=230) The study consists of 2 phases: 1) open-label run-in within maximum 2 months, where all are treated with SZC to test tolarability, and 2) a 1:1 randomized, double-blinded and placebo-controlled treatment during 6 months. The open-label phase, in turn, consists of three periods: run-in (1 - 2 weeks), correc-tion (maximum 72 hours) and maintenance (at least 4 weeks) Sodium Zirconium Cyclosilicate (SZC) (Lokelma)®, 5 g, 10 g, orally, is an approved drug in Sweden. For correction of hyperkalemia, the recommended starting dose is 10 g, three times daily. Once normokalemia has been achieved, the maintenance reg-imen should be started with 5 g once daily. The dose can be titrated up to 10 g once daily or lowered to 5 g once every other day as needed, to maintain a normal level of potassium. Primary Objective: To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimiz-ing MRA in HFrEF, SZC vs Placebo. Primary Outcome Measure: Whether a patient maintains MRA at a dose ≥ 25 mg daily and S-K level in the normal range (3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hyperkalemia at any point during the randomization phase.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lokelma

Condition Name

Condition Name for Lokelma
Intervention Trials
Hyperkalemia 4
Heart Failure With Reduced Ejection Fraction 1
Hyperkalaemia 1
Mineralocorticoid Resistant Hyperkalemia 1
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Condition MeSH

Condition MeSH for Lokelma
Intervention Trials
Hyperkalemia 7
Diabetes Mellitus, Type 2 2
Renal Insufficiency, Chronic 2
Kidney Diseases 2
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Clinical Trial Locations for Lokelma

Trials by Country

Trials by Country for Lokelma
Location Trials
United States 6
United Kingdom 3
Netherlands 1
Belgium 1
Italy 1
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Trials by US State

Trials by US State for Lokelma
Location Trials
California 2
North Carolina 1
Missouri 1
Indiana 1
Georgia 1
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Clinical Trial Progress for Lokelma

Clinical Trial Phase

Clinical Trial Phase for Lokelma
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Lokelma
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Lokelma

Sponsor Name

Sponsor Name for Lokelma
Sponsor Trials
AstraZeneca 4
Michael Fu 1
Barts & The London NHS Trust 1
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Sponsor Type

Sponsor Type for Lokelma
Sponsor Trials
Other 8
Industry 4
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