Combination of Medium Cut-off Dialyzer Membrane and Diet Modification to Alleviate Residual Uremic...
End Stage Renal DiseaseHaemodialysis2 moreThe study will compare achieved levels of protein-bound uremic toxins with dialysis using a medium cut-off membrane compared to the treatment by online haemodiafiltration with a high-flux dialysis membrane. In the second phase of the study dietary fiber and short-chain fatty acid intake will be increased to verify a possible additional reduction in the levels of protein bound uremic toxins.
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
End Stage Renal DiseaseRenal ImpairmentThe primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.
Physical Fitness/Training and Inflammatory Immune Responses in Patients With End-stage Renal Disease...
End-stage Renal DiseaseThe end-stage renal disease (ESRD) leading two causes of death are cardiovascular diseases and sepsis. Exercise improves low physical fitness, available research concerning its effect on the pro-/anti-inflammatory immune response is scarce. In the current proposal, physical fitness is classified into cardiopulmonary fitness and muscle fitness. Muscle fitness is further divided into three domains: strength, mass, and oxidative capacity. The 3-year proposal plan to recruit 90 patients with ESRD who receive regular HD for more than 6 months. Every participant will go through 3 phases:control phase、training phase and the maintenance phase (within-subject design). The hypothesis of the proposal is as follows. (I) When cardiopulmonary fitness/muscle fitness drops to a certain level, the inflammatory immune response will rise. The proposal aims to find the best biomarkers and their cut-off points among the various indicators of cardiopulmonary and muscle fitness that reflect immune dysregulation. (II) Other than physical fitness, cyclic aerobic and resistance training improves pro-/anti-inflammatory immune dysregulation. Additionally, three months after cessation of training, a thorough assessment will be performed to examine whether a healthy lifestyle behavior modification has been achieved and whether the beneficial effect of physical fitness and immune regulation induced by the training program is maintained. The goal of each year is as follows. FIRST year: To explore the relationship between cardiopulmonary fitness and pro-/anti-inflammatory immune response in ESRD patients under HD; SECOND year: To explore the relationship between muscle fitness and pro-/anti-inflammatory immune response; THIRD year: To evaluate the effects of cyclic aerobic and resistance training on physical fitness and pro-/anti-inflammatory immunomodulation in ESRD patients under HD.
Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Chronic Renal FailureDiabete Type 21 moreMain objective: To assess the effectiveness of treatment with symbiotics on the chronic systemic inflammation observed in chronic renal failure 4 months after the start of treatment.
Exercise and Cardiac Stunning During HD
End-stage Kidney DiseaseHemodialysisThe purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
End Stage Renal DiseaseHypertension2 moreKidney 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.
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
End Stage Renal Disease on HemodialysisThis is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.
Immunological Tolerance in Patients With Mismatched Kidney Transplants
End Stage Kidney DiseaseImmunological Tolerance2 moreThis study seeks to determine if administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance in subjects undergoing combined Human Leukocyte Antigen (HLA) single haplotype-matched related or 0-3 antigen (at A, B, C, DR) HLA mismatched unrelated living donor kidney and hematopoietic stem cell transplantation.
Evaluation of STARgraft-3 for Hemodialysis
End Stage Renal DiseaseThis study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. Estimated enrollment is 15 subjects in this study.
Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
End Stage Renal Disease on DialysisHemodialysis2 moreSodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.