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Hyperkalemia clinical trials

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NCT ID: NCT03799926 Completed - Hyperkalemia Clinical Trials

Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Start date: February 18, 2019
Phase: Phase 2
Study type: Interventional

To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients. To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.

NCT ID: NCT03781089 Completed - Clinical trials for End Stage Renal Disease

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

Start date: June 20, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.

NCT ID: NCT03657875 Completed - Clinical trials for Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)

Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)

Start date: September 15, 2017
Phase:
Study type: Observational

This is a cross-sectional retrospective study of laboratory records of patients who take electrolytes blood tests containing the data of the serum potassium level. This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations.

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: NCT03528681 Completed - Hyperkalemia Clinical Trials

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.

HARMONIZE Asia
Start date: May 6, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48 hours of initial ZS therapy (10g TID).

NCT ID: NCT03337477 Completed - Hyperkalemia Clinical Trials

A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8

ENERGIZE
Start date: February 13, 2018
Phase: Phase 2
Study type: Interventional

The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.

NCT ID: NCT03326583 Completed - Clinical trials for End Stage Renal Disease

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

NCT ID: NCT03303521 Completed - Hyperkalemia Clinical Trials

A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

DIALIZE
Start date: December 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.

NCT ID: NCT03283267 Completed - Hyperkalemia Clinical Trials

A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

Start date: October 24, 2017
Phase: Phase 1
Study type: Interventional

This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.

NCT ID: NCT03253172 Recruiting - Hypertension Clinical Trials

Potassium Supplementation in CKD

K+ in CKD
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45 ml/min/1.73 m2).