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End-Stage Kidney Disease clinical trials

View clinical trials related to End-Stage Kidney Disease.

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NCT ID: NCT05642364 Not yet recruiting - Depressive Symptoms Clinical Trials

Virtual Reality in Hemodialysis to Improve Psychological Well-being

Start date: January 2023
Phase: N/A
Study type: Interventional

The long-term goal is to create behavioral health technologies to advance the science that leverages state-of-the-art technology to delivery psychotherapeutic treatment to individuals on hemodialysis (HD) to improve their emotional well-being, quality of life, and overall health. The objective in this small R01 study is to design a virtual reality (VR) platform, that fully immerses users into a fictitious lifelike environment, to deliver an evidence-based positive psychological intervention and to test whether it improves the emotional well-being of individuals on HD with comorbid depression. In this proposed 2-arm randomized controlled trial, the investigators hypothesize that delivery of psychotherapy in individuals on HD using a VR environment will prove feasible and will result in significant improvements in depressive symptoms, quality of life, and treatment adherence, along with reduced rates of hospitalization when compared to an active control condition-all while serving as a cost-effective and far-reaching platform for expansive dissemination. The Specific Aims are: Aim #1: To develop VR software to immersively deliver the skills taught in a 5-week evidence-based positive psychological intervention in individuals on HD to improve their emotional well-being. Aim #2: To evaluate the acceptability and feasibility of a 5-week positive psychological intervention, delivered using a VR platform through consideration of rates of recruitment, refusal, retention, (non)compliance, and adherence. Aim #3: To test initial efficacy of the VR-based psychotherapeutic intervention, compared to a control arm, on outcomes of depression, psychological well-being, quality of life, treatment adherence, HD sessions missed, and hospitalizations in HD patients. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to individuals on HD, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world. This new therapeutic approach can be used to successfully address the added burden of psychological distress experienced by individuals on HD, with the potential to positively impact their quality of life, engagement in healthful behaviors, and overall healthy longevity. And, these findings will yield data essential for a fully-powered trial testing important health outcomes and biomarkers in individuals on HD.

NCT ID: NCT05642156 Recruiting - Clinical trials for End Stage Kidney Disease

Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis

ISO-UF
Start date: November 2, 2022
Phase: N/A
Study type: Interventional

Patients treated with hemodialysis (HD) bear increased risk of cardiovascular events, which results in high morbidity and mortality among this cohort of patients. Intradialytic hypotension (IDH), which is an independent risk factor for mortality, occurs in up to 20% of hemodialysis session and may lead to myocardial stunning and cerebral ischemia resulting in increased white matter lesions, gastrointestinal ischemia and shunt vessel thrombosis. Due to the deleterious effects of IDH during HD, preventive measurements such as limiting interdialytic weight gain are recommended, but frequently fluid and salt restriction are not adhered to, thus increasing dialysis time or frequency of treatments is a common strategy in those patients.

NCT ID: NCT05614115 Recruiting - Hemodialysis Clinical Trials

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

NCT ID: NCT05558267 Not yet recruiting - Clinical trials for End Stage Kidney Disease

Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

Start date: March 29, 2024
Phase: N/A
Study type: Interventional

16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.

NCT ID: NCT05525507 Recruiting - Clinical trials for Chronic Kidney Diseases

Retro-active Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-identical Kidney Transplants

Start date: December 21, 2022
Phase: Phase 1
Study type: Interventional

The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).

NCT ID: NCT05515991 Recruiting - Clinical trials for End-stage Kidney Disease

Symptom Management in Patients on Dialysis

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis. Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).

NCT ID: NCT05485961 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

Start date: October 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double blind, placebo controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

NCT ID: NCT05430438 Completed - Clinical trials for End Stage Kidney Disease

Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.

NCT ID: NCT05425056 Recruiting - Clinical trials for End Stage Renal Disease

A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

ACCESS2
Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.

NCT ID: NCT05418816 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

SelfWrap-Assisted Arteriovenous Fistulas

SW-AVF
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).