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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT06365684 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

LIBRAL
Start date: April 29, 2024
Phase: Phase 4
Study type: Interventional

Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease. Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis [1]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD. Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed

NCT ID: NCT06364358 Not yet recruiting - Hypertension Clinical Trials

Interactive Computer-adaptive Chronic Kidney Disease Education Program

ICCKD
Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC

NCT ID: NCT06352138 Not yet recruiting - Clinical trials for Anemia of Chronic Kidney Disease

Comparative Study of Two Recombinant Human Erythropoietin Products on Chronic Kidney Disease Patients

ENCASE
Start date: July 2024
Phase: Phase 3
Study type: Interventional

Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis

NCT ID: NCT06348589 Not yet recruiting - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis

Start date: April 2024
Phase:
Study type: Observational

High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.

NCT ID: NCT06344936 Not yet recruiting - Clinical trials for Chronic Kidney Disease(CKD)

Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects

NCT ID: NCT06343727 Not yet recruiting - Frailty Clinical Trials

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: - To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. - To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. - To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.

NCT ID: NCT06337838 Not yet recruiting - Surgery Clinical Trials

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

BRACKETS
Start date: June 2024
Phase: Phase 3
Study type: Interventional

The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.

NCT ID: NCT06332469 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation

INSERT
Start date: April 8, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health.

NCT ID: NCT06330480 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease

Start date: September 2024
Phase: N/A
Study type: Interventional

The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population. This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered. The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase: - Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation. - Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life. - Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines. The primary study outcomes are: Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on: - Participation rate of different screening strategies and phases; - Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors); - Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke); - Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE).

NCT ID: NCT06329622 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.