Clinical Research Directory

Dry Weight Reduction Intervention Via Extra Ultrafiltration

Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations. This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.

Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study

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

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.

Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission

The investigators are examining how adding relative blood volume monitoring (RBVM) to the best clinical practice affects outcomes (length of stay and rehospitalization) among dialysis patients hospitalized for or with volume overload.

DKK3 as a Biomarker of Peritoneal Fibrosis in Peritoneal Dialysis Patients

Peritoneal dialysis (PD) uses the peritoneal membrane as a natural filter to remove waste products from the blood in patients with kidney failure. Over time, the peritoneal membrane can become scarred and less functional - a process called peritoneal fibrosis - which eventually leads to ultrafiltration failure and loss of the PD technique. Currently, there is no reliable early biomarker to detect this process before it causes clinical problems. PERIMARK is a prospective, single-center, observational study investigating whether DKK3 (Dickkopf-3), a protein involved in fibrosis signaling, can serve as an early biomarker of peritoneal membrane deterioration. DKK3 will be measured in urine, peritoneal dialysate and serum at four time points over 12 months (T0: catheter insertion; T1: 12 weeks; T2: 6 months; T3: 12 months). At each follow-up visit, peritoneal membrane function will be assessed by the Modified Peritoneal Equilibration Test (Modified PET) with 3.86% glucose, measuring the sodium dip (ΔDNa) as a marker of aquaporin-1-mediated water transport and D/P creatinine as a marker of small solute transport. The primary endpoint is the intraindividual change in DKK3/creatinine ratio in urine, dialysate and serum from baseline to 12 months. Secondary endpoints include the correlation of DKK3 with the sodium dip, longitudinal changes in peritoneal transport parameters, and the exploratory question of whether an early DKK3 rise predicts a later decline in aquaporin-1 function. The study also includes a biobank of serum, urine, dialysate supernatant and cell pellets for possible future analyses. Target enrollment is 25-30 patients.

Pivotal Study of the Velocity™ pAVF System

This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used. The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis. The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years. Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.

Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation

Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function. Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.

Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities

This is a multicenter, prospective, observational real-world study designed to evaluate clinical effectiveness, quality of life, and healthcare resource utilization in patients with end-stage renal disease (ESRD) initiating dialysis therapy in China. Participants will be grouped according to the dialysis modality selected through routine clinical practice and shared decision-making with their treating physicians: remote patient monitoring-assisted automated peritoneal dialysis (RPM-APD), manual peritoneal dialysis (PD), or maintenance hemodialysis (HD). No study-specific interventions will be assigned. The study will compare outcomes across these cohorts, including quality of life, social reintegration, clinical outcomes (e.g., complications and survival), and healthcare resource utilization. Propensity score matching will be applied to adjust for baseline differences between cohorts.

the Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Hemodialysis Patients

the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients

Multi-Site STARgraft (10401) Trial

This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).

AVF Stenosis by Electronic Stethoscope

The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals. \* Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope? This study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.

Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over Trial

This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses. During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week. During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells. The study aims to: * Assess whether the dialyzer membrane influences leukocyte and platelet activation . * Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation. * Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.

To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).

Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients

Chronic kidney disease (CKD) and periodontitis share a bidirectional inflammatory relationship, with cytokines such as IL-6, TNF-α, and hsCRP driving progression in both conditions. Non-surgical periodontal therapy (NSPT) has shown reductions in systemic inflammatory markers with emerging evidence of improved renal function, yet robust randomized controlled trials targeting pre-dialysis stage IV-V diabetic CKD patients remain lacking. In the Indian context, where diabetes-related CKD is rapidly rising and access to dialysis is limited, there is a clear lacuna in literature regarding the effectiveness of NSPT in delaying progression to end-stage renal disease. Hence, the present non-randomized clinical study is undertaken to address this gap.

RaDIANT Health Systems Intervention

The overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start.

Outcome of BCF Access in Hemodialysis Patients

Dialysis access, which is the connection that allows blood to flow in and out of the body during dialysis sessions, is important to remove wastes and excess fluid for patients with end stage renal disease (ESRD). One method used to access the vein and artery for dialysis is called a brachiocephalic fistula. Patients are being asked to participate in this study because they have endstage renal disease, and their doctor has recommended that they will have brachiocephalic fistula placed for their dialysis access. A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS causes problems with the opening of the veins and arteries needed for dialysis. Once someone suffers CAS they may need several radiology procedures as well as surgery to help correct the problem. The BCF may fail once CAS develops. The purpose of the research study is to gather information about the BCF and what is happening inside the vein. The researchers hope to find out what may be the cause of CAS.

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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.

Probiotic and Synbiotic Supplements in Hemodialysis Patients

This single-center randomized controlled trial evaluated the effects of natural probiotic and synbiotic supplementation on clinical and biochemical characteristics in adults with end-stage renal disease receiving maintenance hemodialysis at the Urology and Nephrology Center, Mansoura University, Egypt. Participants were randomized into three groups (control, probiotic, and synbiotic), with supplementation given for 6 months in the intervention groups. The study assessed changes in uremic toxins (including p-cresyl sulfate) as the primary outcome, and cardiovascular parameters, quality of life, and cognitive function as secondary outcomes. The trial aimed to determine whether modulation of gut microbiota with probiotics or synbiotics can improve outcomes in hemodialysis patients

Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)

Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin. Knowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity. The study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective and prospective comparison of patients with chronic kidney disease and calciphylaxis to matched patients with chronic kidney disease who did not develop calciphylaxis thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.

Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal

People with advanced kidney disease need dialysis to remove waste products from the blood. Some of these waste products, called uremic toxins, are small, while others are medium-sized and more difficult to remove. Poor removal of these toxins may contribute to symptoms and long-term complications in patients on dialysis. Two dialysis techniques are commonly used to improve toxin removal beyond standard hemodialysis: expanded hemodialysis (HDx) using medium cut-off membranes, and high-volume online hemodiafiltration (HV-OL-HDF). Although both techniques are effective, the best way to prescribe expanded hemodialysis-particularly the ideal treatment time-has not been clearly defined. The purpose of this study is to compare how well different treatment times of expanded hemodialysis remove small and medium-sized uremic toxins, and to compare these results with high-volume online hemodiafiltration. Toxin removal will be evaluated using a combined measurement called the Global Removal Score, which summarizes the removal of several important waste substances. This is a single-center, randomized, open-label, crossover study. Adults receiving maintenance hemodialysis will receive three different expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), followed by one session of high-volume online hemodiafiltration. Blood samples will be taken before and after each dialysis session to measure toxin levels. The results of this study may help determine whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal similar to high-volume hemodiafiltration, which could support more personalized and practical dialysis prescriptions.

Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients

The goal of this clinical trial is to determine whether a plant-focused diet improves nutritional and health outcomes of malnourished adults undergoing peritoneal dialysis (PD). It will also learn about the safety of this diet in this population. The main questions it aims to answer are: 1. Does a plant-focused diet improve nutritional status compared to a standard kidney diet in PD patients? 2. What changes occur in anthropometric, biochemical, and dietary measures over 6 months? Researchers will compare the plant-focused diet to a standard-of-care renal diet to see which is more effective in improving nutrition in PD patients. Participants will: * Be randomly assigned to follow the plant-focused diet or the standard diet. * Be monitored for 6 months through in-person visits (aligned with their routine clinic appointments) and virtual check-ins via messages or calls. * Have their progress monitored for changes in outcomes such as nutrition, blood tests, kidney function, and quality of life.

EndoForce Post Approval Study

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.

Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Impact of APP-assisted Patient Management on the Quality Control of Blood Purification Therapy

Many maintenance hemodialysis (MHD) patients develop negative outlooks due to their illnesses and complications, making their quality of life and prognosis a clinical concern. Effective life management and treatment cooperation are crucial to improving dialysis quality and patient outcomes. This trial aims to evaluate whether management through the "Yueya" mini-program and WeChat can provide personalized guidance such as health education, diet, exercise, medication supervision, and condition monitoring to enhance treatment compliance, quality of life, strengthen quality control in the hemodialysis unit, and improve patient prognosis. Patients will be divided into a group receiving support via the "Yueya" mini-program and WeChat, and a control group receiving routine care. Clinical and laboratory indicators, cardiovascular events, death, hospitalization, quality of life, and compliance will be recorded and compared between groups to assess the impact of APP-assisted patient management on the quality of MHD blood purification therapy and the prognosis of MHD patients.