View clinical trials related to End Stage Renal Disease.
Filter by:This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.
The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).
In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC. Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months (CYC group).
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab. The trial will examine the safety and efficacy of human polyclonal IVIG 10%, when given at [2.0 gm/kgx2], + Rituximab 1gm to reduce donor-specific antibodies (DSA) to a level that is permissive for transplantation in 75 subjects (adults only ages >18 yrs) who are highly-HLA sensitized and are awaiting deceased donor kidney transplant. Once transplant offers are entertained, a donor-specific crossmatch will be performed. If acceptable crossmatches and DSA levels are seen, the patients will proceed to DD transplantation. Patients receiving transplants will receive an additional dose of IVIG at transplantation (within 10 days) and will receive additional doses of Rituximab 1g at 3M post transplant if DSA levels remain or become positive at 6M if de novo DSA occur. Patients who are desensitized and not transplanted at 9M after desensitization will have completed the study and can be treated as best judged by their physician.
Dialysis patients often suffer from defects in their immune system (that part of the body which fights infection). Evidence suggests that Vitamin D deficiency may have a negative effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that by giving Vitamin D to dialysis patients who are deficient, we may help improve their immune system. This study will test that idea.
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 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.