Clinical Research Directory

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.

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.

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.