A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants...
End-Stage Renal DiseaseThe purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on maintenance hemodialysis (a method used to remove waste material from the blood when the kidneys are unable to do so).
Goal Directed Fluid Administration for Kidney Transplantation
End Stage Renal DiseaseThe goal of the proposed study is to evaluate the efficacy of a goal-directed fluid administration algorithm on early graft function in patients undergoing kidney transplantation. Fluid administration has increasingly been scrutinized within anesthesia related literature as an area for improvement, and the imbalance present between estimated blood loss and total fluid administered for kidney transplants must be amongst the highest case categories. Considering the patients are anuric for the majority of the procedure, unguided administration of multiple liters of crystalloid appears antiquated.
Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study).
Kidney FailureChronicVolume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function. Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested. The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).
End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
End-stage Renal DiseaseThe purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. The investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients...
Kidney FailureChronic4 moreThe purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
End Stage Renal DiseaseThe InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and...
Hepatitis CSafety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)...
End Stage Renal Disease (ESRD)Chronic Kidney Disease (CKD)3 moreThis is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
End Stage Renal DiseaseChronic Kidney Disease Stage 51 moreThe purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.
Trial of Adoptive Immunotherapy With TRACT to Prevent Rejection in Living Donor Kidney Transplant...
End Stage Renal DiseaseRegulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been shown to control immune responsiveness to alloantigens and significantly contribute to operational tolerance in transplantation models (15, 16). However, there have been limited efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for controlling graft rejection and inducing transplantation tolerance, such as for kidney transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the following cell properties could be necessary: ex vivo generation of sufficient numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in an alloantigen-specific manner, and survival/expansion after infusion for a critical, but currently unknown, period of time. Our published work and that of other investigators has demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention of allograft rejection in animal models (15,16). We have developed strategies for the ex vivo expansion of naturally occurring human Tregs (nTregs) that allow for the practical employment of this cellular therapy in the clinic. Our central hypothesis is that sufficient human nTreg can be expanded ex vivo and used to both prevent renal transplant rejection and facilitate the reduction and subsequent withdrawal of drug-based immunosuppression. This study will allow for us to define the safety of Treg adoptive cellular transfer (TRACT) in living donor renal transplant recipients that draws upon our extensive preclinical experience with expanded Tregs, as well as our recognized clinical expertise with designing immunosuppressive regimens compatible with this type of therapeutic cell transfer.