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Showing 1-20 of 147 trials
NCT07165015
The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants.
NCT07466329
Objectives and Scope:This observational study aims to leverage real-world data from Huashan Hospital to develop an AI-driven intelligent decision-making system for assessing dialysis adequacy in maintenance hemodialysis (MHD) patients, and to analyze early warning factors contributing to inadequate dialysis. Core Research Question:Can an AI-based early warning and diagnostic model, built on multidimensional big data, identify the risk of inadequate hemodialysis at an ultra-early stage and accurately diagnose composite complications such as cardiovascular and cerebrovascular diseases? Methodology:The study will conduct a retrospective analysis of adult MHD patients treated at Huashan Hospital between January 2011 and September 2025. The dataset encompasses multidimensional variables, including sociodemographics, treatment parameters, laboratory indicators, metabolomics, and physical functions. Utilizing Dynamic Network Biomarkers (DNB) technology to screen for early warning markers, combined with artificial intelligence algorithms such as Neural Networks and Support Vector Machines (SVM), the study will construct two primary models: "Ultra-early Warning" and "Disease State Diagnosis." These models are designed to provide clinical decision support for precise interventions.
NCT06609343
Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients. In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.
NCT07364292
International guidelines for kidney failure emphasize the importance of aligning renal replacement therapy (RRT) modality selection with individuals' preferences through high-quality, structured education. However, observational qualitative studies suggest that pre-dialysis education remains inconsistently delivered, with substantial centre-to-centre variation in the content and organization of Belgian pre-dialysis programs despite a shared healthcare policy. Multiple barriers to home-based therapies have been repeatedly reported at both the unit and patient levels, including nursing shortages, limited availability of trained staff, financial constraints, high rates of unplanned dialysis initiation, distress at treatment start, low health literacy, and an increasingly frail and comorbid patient population. Yet, a minority of dialysis units appear able to mitigate these barriers more effectively than others. This discrepancy raises concern that centre-oriented priorities (unit throughput, cost-effectiveness, technical performance) may still outweigh patient-centred goals (supporting life priorities and meaningful shared decision-making). This study aims to explore nephrologists' beliefs, knowledge, and attitudes regarding shared decision-making in dialysis modality selection and their potential influence on the adoption of alternative RRT modalities beyond in-centre hemodialysis. Q methodology will be used to capture and compare shared viewpoints and patterns of disagreement across participants.
NCT07146854
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
NCT04163614
Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.
NCT04580420
The aim of this study is to evaluate DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.
NCT05735743
MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (MOVE)) delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. It involves completion of surveys by patients enrolled in the study. It also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (MI).
NCT03719339
The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.
NCT06190717
This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.
NCT03183245
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
NCT05654103
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF. This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
NCT05159999
The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of \<140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
NCT03781089
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.
NCT03994471
Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.
NCT05309109
In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality. Several factors, including inflammation, oxidative stress, metabolic disorders, loss of nutrients, diabetes, retention of middle molecule uremic toxins and dialysis procedure contribute to PEW. It has been previously reported that intensive HD treatments such as short daily and nocturnal HD may improve nutritional parameters. Moreover, post-dilution Online hemodiafiltration (OL-HDF) may also improve PEW by preserving lean body mass evaluated by bioimpedance analysis (BIA) probably through decreased inflammation, stimulation of appetite and better removal of uremic toxins. The recently developed medium cut-off dialyzer (MCO) in HD has demonstrated efficient depuration of middle uremic toxins as compared to high flux HD (HF-HD), similar to that of OL-HDF. Both MCO-HD and OL-HDF may exert beneficial effects on PEW, since they increase removal of higher weight middle molecules, which mostly encompass proteins related to inflammation and PEW in the uremic milieu
NCT06842927
The goal of this prospective diagnostic test (correlation) study is to develop and investigate the performance of artificial intelligence in predicting peritoneum transporter status and dialysis efficiency in adult patients undergoing peritoneal dialysis (PD). The main questions it aims to answer are: Can artificial intelligence predict peritoneal transporter status based on simple clinical and biochemical measurements? Can artificial intelligence predict dialysis adequacy (Kt/V) using these features? Researchers will compare the performance of the AI model with the gold standard Peritoneal Equilibration Test (PET) and Kt/V to evaluate its accuracy and reliability. Participants will: Provide peritoneal dialysate and spot urine samples for biochemical analysis. Undergo routine dialysis adequacy and peritoneal equilibration testing (PET). Have clinical and laboratory data collected for AI model training and validation. The study will recruit approximately 350 peritoneal dialysis patients, with 280 participants in the training/validation arm and 70 participants in the test arm. The study duration is 12 months following enrollment.
NCT06329310
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
NCT05418816
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).
NCT05915286
This pilot trial will evaluate the use of diuretic medications (furosemide and chlorthalidone) in participants on dialysis to see if these medications work to preserve existing kidney function, increase urine output, and reduce weight gain between dialysis treatments. Diuretics, which are sometimes called water pills, help the body to get rid of salt (sodium) and water. There are currently no guidelines for the use of diuretic medications in dialysis patients, including the type to use, or how much to use.