Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
End Stage Renal DiseasePrimary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment. Secondary Objectives: The secondary objectives are to prospectively assess and compare the following parameters in subjects receiving PD or HD treatment: Technique failure Cause of death Comorbidity status at baseline and changes throughout the study Change in residual renal function (RRF) Dialysis adequacy (i.e., Kt/Vurea) Change in blood pressure, hemoglobin, and S-phosphate Change in nutritional status Occurrence of bacterial and other infections Hospitalization, including number, duration, and underlying reason(s) Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP) Quality of life (QOL) Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious adverse events (SAEs), including abnormal laboratory test findings with clinical significance, in subjects receiving PD or HD treatment.
MMF and Calcineurin Inhibitor Withdrawal in CAN
Immunosuppressive AgentsKidney Failure2 moreProspective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in patients with histologically proven chronic allograft nephropathy Indication: change in immunosuppressive treatment of chronic allograft nephropathy (CAN)after renal transplantation Hypothesis: Antimetabolite MMF is able to stop progression of CAN and improve blood pressure/ metabolic parameters and structural vessel wall changes Primary Target:effects of CNI withdrawal and MMF on renal function: stabilisation and/or improvement Secondary Targets: Incidence of adverse events Evaluation of the calcineurin inhibitor free MMF treatment effects on blood pressure, lipids, glucose metabolism and on structural and functional vesselwallchanges Method:open prospective, randomized two-tailed, monocentric study
Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients...
Kidney TransplantationChronic Kidney FailureThe toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in patients with mild impairment of renal function in order to minimize the toxicities of CNI.
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis...
Intradialytic HypotensionEnd Stage Renal Disease1 moreThe purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.
Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease
AnemiaChronic Kidney Disease1 moreTo evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene...
End Stage Renal DiseaseThe purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and...
End Stage Renal DiseaseProspective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
Cardiac Arrhythmia in Patients With End-Stage Renal Disease
End Stage Renal Disease on DialysisCardiac Arrhythmia2 moreThe study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.
Anesthetic Technique for AV Fistulae Creation
End Stage Renal Failure on DialysisThis study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.
Study on Fistuloplasty Using Flow Measurement Guidance
End Stage Renal Failure on DialysisRenal FailureHypothesis: The primary objective of this study is to assess whether using a flow measurement device, in this case the Transonics flow device, as an end-point to interventional treatment of diseased dialysis fistulae can help increase immediate treatment success in terms of quality of dialysis immediately following the treatment and increasing time to reintervention.