View clinical trials related to End Stage Renal Disease.
Filter by:Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs). This study aims to demonstrate that high cut-off hemodialysis is effective in reducing chronic inflammation and thereby improving response to ESAs.
The main purpose of this study is to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with end-stage renal disease undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Main eligibility criteria Males or non-pregnant, non-breast-feeding females, age 18 years, on thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0), Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0), Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (Visits 2 or 3), taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination and serum ferritin less than 1000 micrograms/L and less than TSAT 50% at the Screening Visit (Visit 0).
It is hypothesized that bioimpedance spectroscope guided fluid management will help patient reach euvolemic status, and increase long term survival. Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia. Observational data using BIA methods showed that hypervolemic patients on maintenance hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management comparing with standard care. Design: This is a multicenter, prospective, randomized, controlled trial. Setting and Participants: More than 1300 participants from 16 clinical sites will be included in the study. The enrollment period will last 6 months, and minimum length of follow-up will not less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been on MHD for at least 3 months and considered suitable candidates will be invited to participate in the study. Participants will be randomized to BIA arm or control arm using 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM arm. Predictors: BCM guided fluid management and fluid management using standard care. Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint between BCM arm and control arm. The secondary intent-to-treat analysis compares left ventricular thickness, blood pressure, medication, and incidence and length of hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke, peripheral arterial disease will be used as composite endpoint.
The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD). The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland Aggregate Pathology Index) score is a preimplantation donor scoring system which has five histopathological parameters that impact long-term kidney outcomes. Many kidney transplant recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations. Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept therapy (BMS) instead, may be associated with improved kidney transplant outcomes.
To investigate the relationship between dietary intake, body habitus, and endocannabinoid levels in end stage renal disease patients as compared to matched controls.
A pilot randomized trial that compares a new renal nutritional supplement with the standard renal vitamin. The primary objective is to compare two doses (medium and high) of the new supplement with the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD). Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger trial.
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.