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Hyperkalemia clinical trials

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NCT ID: NCT04955678 Completed - Hyperkalemia Clinical Trials

A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

Start date: August 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.

NCT ID: NCT04799067 Completed - Hemodialysis Clinical Trials

Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

PRECEDE-K
Start date: May 17, 2021
Phase:
Study type: Observational

The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.

NCT ID: NCT04788641 Completed - Hyperkalaemia Clinical Trials

Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.

NCT ID: NCT04780841 Completed - Hyperkalemia Clinical Trials

A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

Redukx
Start date: January 11, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels

NCT ID: NCT04566653 Completed - Clinical trials for Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia

APPETIZE
Start date: October 23, 2020
Phase:
Study type: Observational

This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.

NCT ID: NCT04466969 Completed - Hyperkalemia Clinical Trials

Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study

HKRegistrypilo
Start date: July 31, 2020
Phase:
Study type: Observational

Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome(PROs) which will be used in the Hyperkalemia(HK) registry study in hyperkalemia patients with Chronic Kidney Disease(CKD) or Heart Failure(HF) to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia

NCT ID: NCT04256369 Completed - Hyperphosphatemia Clinical Trials

Rate of Termination of Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolytes

Start date: February 2, 2020
Phase:
Study type: Observational

Introduction: Various commercial premixed parenteral nutrition (PN) solutions have been introduced to clinical practice in 3-compartment large volume bags. Olimel N9E is the formulary premixed PN formula at King Faisal Specialist Hospital and Research Centre (KFSH & RC). The commercial premixed PN was associated with a significant cost reduction compared to the compounded PN, with lower incidence of infectious complications, compared to the compounded PN formula. Electrolyte irregularities are commonly encountered with PN use. Patients who develop high serum potassium, magnesium or phosphate levels while receiving premixed PN are shifted to a compounded PN with lower electrolyte content. This study aims to describe the incidence of shifting of premixed PN to a compounded PN secondary to high serum electrolytes in surgical patients receiving commercial premixed PN. Methods: This is a prospective, cohort, study, to be conducted at KFSH & RC, Riyadh. This study is proposed to commence after obtaining the approval of the Research Ethical Committee at KFSH & RC. Patients enrolment will start after the approval at KFSH & RC, by data collection phase, that might extend for a suspected 6-month until achieving the target sample size of 55 patients. The analysis phase will follow and elapse for 2 months. This is followed by 2 months to get the initial abstract. All patients will have their potassium, magnesium, calcium and phosphorus levels assessed daily in the morning for the first 7 days of PN initiation. After the first week of PN support, according to the routine laboratories, electrolytes will be assessed at a minimum of three times a week thereafter while on PN. There will be no extra laboratory work obtained for the study purpose. The incidence of shifting from premixed PN to compounded PN will be assessed and reported. A description of the characteristics of patients who develop high serum level of electrolytes will be undertaken using regression analysis.

NCT ID: NCT04251468 Completed - Hyperkalemia Clinical Trials

Clinical Potassium Pilot Study

Start date: April 29, 2020
Phase: N/A
Study type: Interventional

In this pilot study, 30 prevalent hemodialysis patients will undergo three regular hemodialysis sessions during which various potassium assessments will be performed. Pre- (t1) and post-dialysis (t2) plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes. These values will be correlated to K+ determine in saliva probes (K+Sa) using genetically encoded potassium ion indicators (GEPIIs). Additionally, continuous ECG will be recorded during each hemodialysis treatment and potassium assessment (K+ECG) will be performed upon ECG-based parameters and correlated to K+Pl.

NCT ID: NCT04217590 Completed - Hyperkalemia Clinical Trials

Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects

DIALIZE China
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.

NCT ID: NCT04207203 Completed - Hyperkalemia Clinical Trials

Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study

HELPFUL
Start date: November 3, 2020
Phase: N/A
Study type: Interventional

This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be normalized with the use of SZC and then the participants will receive a fruit basket during 3 weeks. SZC will be continued thru out the study. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.