View clinical trials related to End Stage Renal Disease.
Filter by:This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > > > > > > A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. > > > > > > Subjects will be selected from up to 20 Investigational Sites.
Peritoneal dialysis (PD) is an established dialysis modality in patients with end stage renal disease (ESRD). However, there is growing awareness of the deleterious effect of high glucose content in PD solutions on the peritoneal membrane over time (1). Accordingly, development of new solutions to minimize glucose-induced toxicity and/or containing an alternative osmotic agent to glucose such as icodextrin and amino-acid were developed. Icodextrin is a mixture of high molecular weight, water soluble glucose polymers isolated by fractionation of hydrolyzed cornstarch (2). Unlike glucose which is absorbed from the peritoneal cavity primarily by diffusion across the peritoneal capillary endothelium, its absorption occurs mainly due to convective fluid movement out of the peritoneal cavity via the lymphatics (2). As a result, relatively constant osmotic pressure is created by icodextrin, thus it can provide sustained ultrafiltration during the long dwell. A number of studies have reported that icodextrin-based solution provides various clinical benefits compared with conventional glucose-based solutions (3-7). In particular, icodextrin has been successfully used in the fluid management of PD patients (4-5, 7). However, excessive ultrafiltration may induce underhydration, resulting in faster decline in residual renal function. This concern was first raised by Konings et al (8). In this study, a greater fall in residual glomerular filtration rate (GFR) was observed in patients using icodextrin compared to those using 1.36% glucose solution. In contrast, contradictory findings were also reported from the two studies indicating that residual renal function can be preserved by icodextrin solution (4, 9). Although the mechanisms are not clear, possible explanation includes the presence of high-molecular-weight icodextrin metabolites in plasma, which in turn may increase plasma oncotic pressure and hence preserve plasma volume and renal perfusion as suggested by Davies et al (10). Such discrepant findings may be explained by differences in study design, baseline fluid status, and other factors affecting residual renal function during the study. In the study by Konings et al (8), the comparative solution was 1.36% glucose, whereas 2.27% glucose was used in the study by Davies et al (4). Therefore, it can be speculated that volume status might differ depending on different concentration of glucose solution, thus leading to conflicting results. Also, these two prior studies are limited by residual renal function as secondary outcome, a short follow-up duration (4 mo vs. 6 mo), and small number of patients (32 vs. 50). To further explore the effects of icodextrin solution on residual renal function, the investigators will conduct a multicenter prospective randomized controlled open-label trial. Briefly, incident or prevalent adult CAPD patients with residual urine volume > 750 ml will be included. Patients on APD will be excluded. After a 4-week screening period, patients will be randomly assigned to icodextrin or 2.5% glucose solution for the long dwell. Residual GFR and fluid status will be assessed at baseline, 6, and 12 months. Residual GFR will be calculated as an average of urea and creatinine clearance from a 24-hour urine collection. To assess fluid status, the investigators will use three different assessment tools; 1) echocardiography for measuring intra vena cava (IVC) diameter and left ventricular end diastolic diameter, 2) measurement of plasma atrial natriuretic peptide, 3) bioimpedence analysis. Primary outcome is residual GFR change at 1-year and secondary outcome is change of fluid status during the study period. Also, biochemical laboratory data such as hemoglobin, hsCRP, plasma osmolality, and lipid profile, peritoneal equilibration test, dialysis adequacy, and daily peritoneal glucose exposure will be monitored. At least 50 subjects (a total of 100) would be required for each group to detect 50% difference of residual GFR between the two groups if type I error rate is 5% and type II error is 20% given 30% of drop-out rate during the study period. Preservation of residual renal function is of paramount importance because it is an independent risk factor of mortality in PD patients. In addition, achievement of adequate ultrafiltration is another crucial therapeutic goal to improve clinical outcomes in these patients. In this regard, if these two goals can be accomplished by icodextrin, it would be an ideal dialysis solution in PD practice. The investigators study will address this issue to answer the unresolved question on the effect of icodextrin on residual renal function."
The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response. In general, induction therapy is associated with better outcomes compared to the absence of induction therapy. However, currently used induction agents, some of which are not labeled or indicated for induction therapy in transplantation, have drawbacks related to long-term immune system suppression increasing susceptibility to opportunistic infections or malignancies, and other immune-mediated side effects. An unmet medical need exists for a more specific approach to prevent acute organ rejection, without unnecessarily exposing the patient to non-specific or open-ended immune suppression, which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody that targets a very specific immune cell type that is critical in the acute organ rejection response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus in first time kidney transplant recipients. This study will test the hypothesis that a more specific approach (with TOL101) to prevention of acute organ rejection may provide similar or better efficacy than the currently used induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer risks in terms of opportunistic infections, malignancies and adverse effects.
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
Vascular access complications are the leading cause of morbidity in hemodialysis (HD) patients, and are responsible for a significant percentage of hospitalization, with annual costs approaching one billion dollars in the United States. Thrombosis is the most common cause of vascular access failure, and usually develops from stenotic lesions in the venous outflow tract. It has been reported that far infrared (FIR) therapy can improve access flow and unassisted patency of AV fistula, however, the effect of FIR on cardiac function is unknown. The aims of this study are to evaluate (1) the change of access flow of AV fistula and the effect of AV fistula on echocardiographic parameters and (2) the effect of FIR on access flow of AVF and echocardiographic parameters and the serum levels of endothelial markers in patients with end stage renal disease (ESRD) during the first 6 months after the creation of AV fistula.
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).
Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis. By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.