| Lokelma (sodium zirconium cyclosilicate) / AstraZeneca |
2020-003312-27: A study to assess the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) for the Management of High Potassium in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone |
|
|
| Ongoing | 4 | 428 | Europe | Sodium zirconium cyclosilicate 5 g., Sodium zirconium cyclosilicate 10 g., Powder for oral suspension, Lokelma | AstraZeneca AB, AstraZeneca AB | Hyperkalemia in Patients with Symptomatic Heart Failure., Hyperkalemia means that the potassium level in the blood is higher than normal., Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
ChiCTR2100046689: Sodium Zirconium Cyclosilicate for treatment of hyperkalemia in hemodialysis patients: a multi-center, randomized, controlled study |
|
|
| Recruiting | 4 | 196 | | Sodium Zirconium Cyclosilicate ;Insulin and glucose | The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, Astrazeneca Pharmaceutical Co.,Ltd. | Hyperkalemia in hemodialysis patients | | | | |
2019-000595-42: Effect of Lokelma on protein in the urine in persons with diabetes and elevated potassium Effekt af Lokelma på protein i urinen hos personer med diabetes og forhøjet kalium |
|
|
| Not yet recruiting | 4 | 100 | Europe | Powder for oral suspension, Lokelma | Steno Diabetes Center Copenhagen, AstraZeneca | Treatment for proteinuria in type 1 or type 2 diabetes with hyperkalemia, Elevated protein in the urine in subjects with type 1 or type 2 diabetes and elevated potassium in the blood., Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
2020-000695-38: Healthy diet containing fruits, vegetables and nuts to patients with renal insufficiency thought the use of potassium binder (sodium zirconium cyclosilicate): A Study Test |
|
|
| Not yet recruiting | 4 | 36 | Europe | Lokelma, Powder for oral solution in sachet, Lokelma | Karolinska Universitetssjukhuset, Astra Zeneca | Chronic kidney disease, stages 4 and 5 of the disease, Renal insufficiency, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
ADAPT, NCT05535920: A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia |
|
|
| Completed | 4 | 88 | US | LOKELMA 5 GM Powder for Oral Suspension | NephroNet, Inc., AstraZeneca | Hyperkalemia | 04/24 | 04/24 | | |
ChiCTR2200057589: Lokelma to Enable ACEIs/ARBs Use in the Treatment of Patients with Diabetic Kidney Disease |
|
|
| Not yet recruiting | 4 | 86 | | Sodium zirconium cyclosilicate combined with ACEIs/ARBs was administered ;ACEIs/ARBs were treated separately | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Astrazeneca Investment (China) Co., Ltd. will provide full financial and pharmaceutical support | DKD | | | | |
LIBRAL, NCT06365684: Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4 |
|
|
| Recruiting | 4 | 16 | Europe | Sodium zirconium cyclosilicate, Lokelma | Leiden University Medical Center, AstraZeneca | Hyperkalemia, Diet Modification, Chronic Kidney Disease, Sodium Zirconium Cyclosilicate | 05/25 | 05/25 | | |
| Recruiting | 4 | 120 | US | Polyethylene Glycol 3350, MiraLax, Sodium Polystyrene Sulfonate Oral Suspension [SPS], Kayexalate, Patiromer, Veltassa, Sodium zirconium cyclosilicate, Lokelma | University of California, Irvine | Acute Hyperkalemia, Oral Potassium Binders | 07/25 | 12/25 | | |
| Completed | 4 | 366 | Europe, Canada, US, RoW | Sodium zirconium cyclosilicate, SZC, Placebo, Spironolactone | AstraZeneca, AstraZeneca AB | Hyperkalaemia, Heart Failure With Reduced Ejection Fraction | 07/24 | 07/24 | | |
| Completed | 4 | 186 | Europe | Sodium Zirconium Cyclosilicate (SZC), Lokelma, Local standard of care, SoC | AstraZeneca | Hyperkalaemia, Chronic Kidney Disease | 12/24 | 12/24 | | |
NCT06736184: The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients |
|
|
| Not yet recruiting | 4 | 100 | NA | Sodium Zirconium Cyclosilicate (SZC) | Qianfoshan Hospital | Chronic Kidney Disease on Hemodialysis, Hypokalemia, Hyperkalemia, Myocardial Injury | 12/26 | 12/26 | | |
ChiCTR2300072940: Effect of sodium zirconium cyclosilicate (SZC) on rapid correction of hyperkalemia before kidney transplantation |
|
|
| Not yet recruiting | 4 | 60 | | None | Nanfang Hospital, Southern Medical University; Nanfang Hospital, Southern Medical University, self-funded | Hyperkalemia in chronic kidney disease stage 5 | | | | |
2017-003029-14: The purpose of the study is to test whether ZS (Sodium Zirconium Cyclosilicate) can reduce the incidence of increased blood potassium levels among dialized patients |
|
|
| Not yet recruiting | 3 | 180 | Europe | Sodium zirconium cyclosilicate powder for oral suspension, AZD7270, Powder for oral suspension | AstraZeneca AB, AstraZeneca AB | 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), elevated potassium concentration among patients treated with chronic hemodialysis, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
2020-003229-47: Keeping RAASi treatment with optimal potassium control Manteniendo el tratamiento con iSRAA con un control óptimo de potasio |
|
|
| Ongoing | 3 | 78 | Europe | Powder for oral suspension, Lokelma | Instituto de Investigación Sanitaria INCLIVA, AstraZeneca Farmacéutica Spain, S.A. | Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history Hiperpotasemia en pacientes con enfermedad renal crónica (ERC) e insuficiencia cardiaca, Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history Hiperpotasemia en pacientes con enfermedad renal crónica (ERC) e insuficiencia cardiaca, Diseases [C] - Symptoms and general pathology [C23] | | | | |
| Recruiting | 3 | 78 | Europe | Sodium Zirconium Cyclosilicate, Lokelma | Fundación para la Investigación del Hospital Clínico de Valencia | Chronic Kidney Diseases | 07/25 | 07/26 | | |
| Recruiting | 3 | 140 | Europe, Canada, Japan, US, RoW | Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level, Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1), Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2), Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3), Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase | AstraZeneca | Hyperkalaemia | 06/26 | 06/26 | | |
| Recruiting | 3 | 130 | Europe | Lokelma Oral Product, placebo | St George's, University of London | Chronic Kidney Diseases, Heart Failure With Reduced Ejection Fraction, Hyperkalemia, ACE Inhibitor Induced Hyperkalaemia, Mineralocorticoid Resistant Hyperkalemia | 12/23 | 12/23 | | |
SENEKA, NCT06578078: A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients |
|
|
| Recruiting | 3 | 94 | Europe | Sodium Zirconium Cyclosilicate, Lokelma, Standard of care treatment (RAASi therapy) | Fundación para la Investigación del Hospital Clínico de Valencia | Heart Failure, Chronic Kidney Diseases | 03/25 | 03/26 | | |
STABILIZE-CKD, NCT05056727 / 2021-001911-96: 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 Hyperkalaemia |
|
|
| Terminated | 3 | 716 | Europe, Canada, Japan, US, RoW | Sodium Zirconium Cyclosilicate (SZC), Lokelma TM, Placebo, Lisinopril, Valsartan, Irbesartan | AstraZeneca | Renal Insufficiency, Chronic, Hyperkalemia | 02/24 | 02/24 | | |
| Terminated | 3 | 2690 | Europe, Canada, Japan, US, RoW | Sodium Zirconium Cyclosilicate (SZC), Lokelma TM, SZC Placebo | AstraZeneca | Hyperkalemia | 03/24 | 03/24 | | |
| Not yet recruiting | 2 | 230 | Europe | lokelma, V03AE10, Powder and solvent for oral suspension, Lokelma | Sahlgrenska University Hospital, AstraZeneca | Heart failure, Heart failure is a serious condition, it means that the heart isn’t pumping as well as it should be and it requires seeking timely medical attention, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Terminated | 2 | 10 | Europe | Sodium Zirconium Cyclosilicate, Lokelma, Placebo | Barts & The London NHS Trust | CKD, Diabetes Mellitus, Type 2, Hyperkalemia | 03/23 | 05/23 | | |
OPRA-HF, NCT04789239: OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure |
|
|
| Recruiting | 2 | 110 | Europe | Sodium zirconium cyclosilicate, Lokelma, Placebo | Michael Fu, AstraZeneca, Göteborg University | Heart Failure, Hyperkalemia | 12/26 | 12/26 | | |
NCT04727840: Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial) |
|
|
| Not yet recruiting | 1 | 20 | US | Sodium Zirconium Cyclosilicate Oral Product | Brigham and Women's Hospital | Chronic Kidney Diseases, Hyperkalemia | 01/22 | 01/22 | | |
HELPFUL, NCT04207203: Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study |
|
|
| Completed | N/A | 26 | Europe | sodium zirconium cyclosilicate and healthy diet | Karolinska Institutet, AstraZeneca | Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Hyperkalemia | 04/23 | 05/23 | | |
NCT06029179: SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients |
|
|
| Completed | N/A | 120 | RoW | sodium zirconium cyclosilicate (SZC), sodium polystyrene sulfonate | Alexandria University | Hyperkalemia | 10/24 | 12/24 | | |
ChiCTR2100042510: Clinical research on spironolactone in the treatment of coronary heart disease with renal insufficiency based on heart and kidney remodeling |
|
|
| Recruiting | N/A | 240 | | 20mg spirolactone ;20mg spironolactone+5mg Sodium Zirconium Cyclosilicate Powder ;none | The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University, National Natural Fund | Coronary heart disease with renal insufficiency | | | | |
SHIELD, NCT06185660: 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 Greece |
|
|
| Completed | N/A | 125 | Europe | sodium zirconium cyclosilicate (SZC) | AstraZeneca | Hyperkalaemia | 01/25 | 01/25 | | |
ACTUALIZE, NCT05271266: 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 China |
|
|
| Completed | N/A | 1000 | RoW | | AstraZeneca | Hyperkalaemia | 12/23 | 12/23 | | |
VITALIZE, NCT06635499: .Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain |
|
|
| Recruiting | N/A | 230 | Europe | | AstraZeneca | Hyperkalaemia | 04/25 | 04/25 | | |
