First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
End Stage Renal DiseaseEnd Stage Renal Failure on DialysisA feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients...
End-stage Renal DiseaseKidney Failure1 moreThe purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG. The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With...
Kidney FailureChronic1 moreThe CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
Kidney FailureEnd Stage Renal Disease3 moreThe purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.
Incremental Haemodialysis in Incident Patients
Renal DiseaseEnd-StageBackground: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.
Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated...
End-Stage Renal DiseaseType 2 DiabetesThe study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
End Stage Renal DiseaseHepatitis CIn this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.
Nutritional Interventions in Peritoneal Dialysis Patients With Hypoalbuminemia
End Stage Renal Disease on DialysisInadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in patients on peritoneal dialysis (PD). The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known. The investigators hypothesize that higher dietary protein intake has a greater beneficial effect on nutritional status in hypoalbuminemic PD patients. In particular, 1.5 g/kg protein intake provides a better beneficial effect than 1.2 g/kg protein intake.
Rheopheresis as Adjuvant Treatment of Calciphylaxis
Metabolic DisorderEnd Stage Renal Disease1 moreWe propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.
Impact of Black Seed Oil on Hemodialysis Patients
End Stage Renal DiseaseThe aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.