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Hyperkalemia clinical trials

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NCT ID: NCT05056727 Terminated - Clinical trials for Renal Insufficiency, Chronic

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

STABILIZE-CKD
Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.

NCT ID: NCT04997161 Terminated - Hyperkalaemia Clinical Trials

Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

GRAZE
Start date: August 17, 2021
Phase: Phase 4
Study type: Interventional

Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more satisfying diet. The study aims to show that participants using SZC achieve S-K+ reduction as well as participants on SoC (other than K+ binders), without the need for restricting K+ in the diet.

NCT ID: NCT04983979 Terminated - Clinical trials for Diabetes Mellitus, Type 2

The ORTIZ Study: Optimising RASi Therapy With SZC

ORTIZ
Start date: June 17, 2022
Phase: Phase 2
Study type: Interventional

The hypothesis is that 3 months' treatment with SZC versus placebo will enable RASi (Irbesartan) maximisation in a cohort of patients with diabetic kidney disease.

NCT ID: NCT04847232 Terminated - Hyperkalemia Clinical Trials

Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

NCT ID: NCT04727528 Terminated - Clinical trials for Chronic Kidney Disease

Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease

NEUTRALIZE
Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD

NCT ID: NCT04443608 Terminated - Hyperkalemia Clinical Trials

Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management

PLATINUM
Start date: October 8, 2020
Phase: Phase 4
Study type: Interventional

When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.

NCT ID: NCT03597035 Terminated - Type2 Diabetes Clinical Trials

Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On

MAGMAAddOn
Start date: July 17, 2018
Phase: Phase 4
Study type: Interventional

Patiromer add-on to a mineralocorticoid receptor antagonist (MRA) in patients with Type 2 diabetes mellitus and chronic kidney disease (CKD) will reduce blood pressure and left ventricular (LV) mass to a greater extent compared to patients with MRA alone and favorably affect key secondary hemodynamic and inflammatory variables including atherosclerosis progression. Atherosclerosis is the leading cause of morbidity and mortality in Type II diabetes. A cell type called the monocyte/macrophage is critical to development and complications of atherosclerosis. This project will evaluate the effectiveness of a medication called Spironolactone in addition to Patiromer in preventing atherosclerosis in Type II diabetes through its effects on cells such as the monocyte. Spironolactone has been demonstrated to be effective for the treatment of patients after a heart attack and stroke. The investigators will evaluate the impact of Spironolactone in combination with Patiromer in reducing atherosclerosis plaque and additionally evaluate its potential in changing inflammation. The investigators envision that a strategy of simultaneously probing effect of a drug combined with analysis of mechanisms of action and predictive response will likely provide key information with which to design hard event (heart attack, stroke etc.) based trials.

NCT ID: NCT03087058 Terminated - Hyperkalemia Clinical Trials

Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia

EMERALD
Start date: July 7, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.

NCT ID: NCT03018067 Terminated - Hyperkalemia Clinical Trials

A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia

Start date: January 2017
Phase: Phase 2
Study type: Interventional

This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).

NCT ID: NCT02033317 Terminated - Hyperkalemia Clinical Trials

An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis

Start date: August 2008
Phase: Phase 2
Study type: Interventional

This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.