Clinical Research Directory

Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease

End-Stage Kidney Disease (ESKD) in children is a severe and irreversible condition that significantly impacts their growth, development, and overall quality of life. Children with ESKD often face numerous physical, emotional, and social challenges, including the need for life-saving dialysis or kidney transplantation. Despite advancements in clinical management, dietary adherence remains a critical component in managing ESKD and improving health outcomes. This study will compare two approaches to providing medically tailored meals (MTMs) for children with ESKD. A total of 30 children and their parents or caregivers will be randomly assigned to one of two groups: (1) a culinary medicine program that teaches families how to plan, shop for, and prepare kidney-friendly meals at home, or (2) a program that provides pre-prepared, kidney-friendly meals delivered to their homes. The study will assess how practical and acceptable each approach is for families and examine its potential effects on children's health and dietary habits. Researchers will evaluate participation, satisfaction, and study completion rates. They will also examine changes in children's blood potassium and phosphorus levels, blood pressure, fluid balance, diet quality, and health-related quality of life. In addition, the study will explore whether the culinary medicine program improves parents' nutrition knowledge, confidence in preparing healthy meals, meal planning, grocery shopping, cooking skills, and availability of healthy foods at home. Researchers will also compare the costs of the two approaches, including food, educational materials, and staff time, to estimate the cost per child. The findings will help determine whether these approaches are practical for families and provide information to guide future studies and programs to improve nutrition and health among children with ESKD.

Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial

The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study. Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future. Participants will: * Be assigned by chance to one of the two blood pressure goals. * Have their blood pressure measured at clinic visits about every two weeks. * Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal. * Be part of the study for about four and a half months.

Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring

This study will evaluate whether Continuous Glucose Monitoring (CGM) can identify previously unrecognized diabetes and clinically significant hyperglycemia in adults with end-stage kidney disease (ESKD) receiving hemodialysis who have no known history of diabetes. Participants will wear a CGM sensor for up to 15 days and undergo standard diabetes assessments, including fasting plasma glucose and hemoglobin. The primary objectives are to: * Determine the prevalence of previously undiagnosed diabetes among dialysis patients using OGTT criteria. * Compare CGM glucose patterns between participants with and without diabetes as determined by OGTT results.

Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease

Patients with end-stage kidney disease (ESKD) undergoing hemodialysis or peritoneal dialysis experience a high burden of symptoms, including fatigue, pain, pruritus, muscle cramps, and sleep disturbances, which substantially affect health-related quality of life (HRQOL). Although acupuncture has shown potential benefits for several symptoms in this population, evidence regarding its overall effect on HRQOL remains limited, and the underlying biological mechanisms are not fully understood. This prospective, randomized, sham-controlled trial will evaluate the effect of a structured acupuncture protocol on HRQOL and symptom burden in patients with ESKD undergoing hemodialysis or peritoneal dialysis. Participants will be randomized to receive either acupuncture or sham acupuncture in addition to usual care. HRQOL will be assessed using the Kidney Disease Quality of Life 36-item questionnaire (KDQOL-36), while secondary clinical outcomes will assess key dimensions of symptom burden. The study will also investigate changes in selected neuropeptide and proteomic biomarkers associated with pain modulation, neuroinflammation, and neuroendocrine regulation. By integrating patient-reported clinical outcomes with biomarker assessment, the study aims to explore both the clinical effects of acupuncture and the biological mechanisms potentially underlying these effects in patients with ESKD.

Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients

This study aims to compare the effects of medium cut-off (MCO) and high-flux hemodialysis membranes on mineral and bone metabolism biomarkers in patients receiving maintenance hemodialysis. Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by disturbances in biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin, which are associated with bone turnover, vascular calcification, and adverse clinical outcomes. This is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical study. Thirty adult patients receiving maintenance hemodialysis will be randomized to receive either MCO membrane treatment followed by high-flux membrane treatment or the reverse sequence, with each treatment period lasting three months. Serum FGF-23 and sclerostin levels will be measured at baseline, Month 3, and Month 6. Additional assessments will include pulse wave velocity (PWV), body composition monitoring (BCM), handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain assessment (SF-MPQ). The study will evaluate whether MCO membranes provide additional benefits compared with conventional high-flux membranes regarding CKD-MBD-related biomarkers and patient-centered outcomes.

Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Dialysis Less Frequently in the Elderly

Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.

A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)

This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.