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Endstage Renal Disease clinical trials

View clinical trials related to Endstage Renal Disease.

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NCT ID: NCT03054454 Not yet recruiting - Diabetes Mellitus Clinical Trials

A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure

Start date: April 2017
Phase: N/A
Study type: Interventional

Observational studies clearly show that people with diabetes and end-stage kidney failure have an increased risk of foot ulceration and leg amputation. However, there is very little evidence on addressing this problem. Diabetes foot care teams have been shown to reduce hospital admissions, length of stay and leg amputation in people with diabetes. Since their introduction at The James Cook University Hospital (JCUH) major diabetes-related leg amputation rates have fallen by 86 percent (1995 to 2010). People with diabetes and end-stage kidney failure require haemodialysis (blood cleaning) 3 times per week for several hours each time. This time commitment makes it difficult to attend other clinical appointments. An audit at JCUH shows that this population fails to attend the normal diabetes foot services. This project aims to reduce the incidence of foot disease in people with diabetes and end-stage kidney failure on dialysis. The investigators will set up a podiatry-led intervention within the dialysis unit to prevent and promptly treat foot disease in this population. This will involve foot risk assessment, risk reduction and treatment during dialysis. The intervention will involve diabetes consultants, podiatrists, vascular and orthopaedic surgeons . In this way the investigators hope to reduce leg amputation, hospital admission, procedures to unblock arteries and death in this high risk group. The study will run in the dialysis unit at JCUH. Patients will be divided into two groups: those attending for dialysis on a Monday, Wednesday and Friday will form the treatment group and those attending on a Tuesday, Thursday and Saturday will continue to be managed as at present. The investigators will collect data from patient health care records looking in particular at leg amputations, hospital admissions due to foot problems, foot surgery and operations to unblock arteries.

NCT ID: NCT03023748 Active, not recruiting - Clinical trials for Secondary Hyperparathyroidism

Intravenous Paricalcitol in Chronic Hemodialysis Patients

Start date: September 2011
Phase: Phase 4
Study type: Interventional

This study aims to provide intravenous paritcalcitol treatment for the sick and poor hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D analogs. The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular calcification and stiffness parameters and nutrition status in patients receiving chronic hemodialysis treatment.

NCT ID: NCT03020303 Recruiting - Clinical trials for Endstage Renal Disease

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

ACHIEVE
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.

NCT ID: NCT03010072 Completed - Clinical trials for Endstage Renal Disease

The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

Start date: June 9, 2017
Phase: Phase 2
Study type: Interventional

This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.

NCT ID: NCT02981706 Completed - Clinical trials for Chronic Kidney Disease

Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

Start date: October 6, 2016
Phase: N/A
Study type: Interventional

This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.

NCT ID: NCT02977117 Completed - Clinical trials for Endstage Renal Disease

The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.

NCT ID: NCT02976688 Not yet recruiting - Clinical trials for Endstage Renal Disease

Effects of Short-chain Fatty Acids on Inflammatory and Metabolic Parameters in Maintenance Hemodialysis

PLAN
Start date: January 2017
Phase: Phase 2/Phase 3
Study type: Interventional

End-stage renal disease (ESRD) is associated with multiple comorbidities such as cardiovascular disease, anemia, mineral and bone disorders, malnutrition, body wasting, muscle loss (sarcopenia), neurological problems and infections resulting in a poor survival. In the pathogenesis of the uremic syndrome the altered intestinal function seems to be an important contributor. While the normal gut microbiota plays a prominent role in the maintenance of health and disease prevention, changes of its composition is associated with numerous diseases such as obesity, type 2 diabetes, cardiovascular disturbances and auto-immune diseases.In ESRD metabolic alterations of uremia results in quantitative and qualitative changes of its bacterial flora with an overgrowth of pathobionts (1). Due to concomitant disruption of the intestinal barrier function, noxious luminal products are translocated in the body's internal milieu (2).The accumulation of these compounds correlates with systemic inflammation, protein wasting and accelerated cardiovascular complications in hemodialysis patients (3). Short-chain fatty acids (SCFA) are produced in the colon and distal small intestine by anaerobic bacteria following fermentation of complex carbohydrates.They have been shown to exert anti-inflammatory, anti-cancer, antibacterial and antidiabetic effects (4). Supplementation of SCFA exerts anti-inflammatory actions both in intestinal epithelial cells (5) and in the cardiovascular system (6). They also positively influence auto- immune reactions /diseases (7,8). In this study we want to investigate in MHD patients whether a treatment with SCFA in form of sodium propionate (SP) modulates the systemic inflammation, insulin resistance and accumulation of intestinal uremic toxins.

NCT ID: NCT02976246 Completed - Clinical trials for Cardiovascular Disease

Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients

RenaKvit
Start date: November 2016
Phase: Phase 4
Study type: Interventional

Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20 times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence arterial stiffness is of great importance for the high incidence of CVD. CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both vertebral and other fractures of low energy are associated with a high mortality. Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on vitamin K. Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is reflected in very low concentrations of vitamin K in their blood samples. A correlation between vitamin K level, incidence of vascular calcification and bone density has been proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular calcification or bone strength. The investigators will conduct a randomized placebo controlled trial examining the clinical effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent and treat CVD and bone disease in CKD ptt. Primary study endpoints: 1. Changes in arterial stiffness assessed by pulse wave examination 2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans. Secondary study endpoints: Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood pressure, body composition, total and regional BMD, lateral column/aortic calcification score as well as a panel of correlating blood tests.

NCT ID: NCT02970201 Completed - Clinical trials for Endstage Renal Disease

Improving Adherence in Renal Dialysis Patients Through Electronic Interventions

Start date: February 2015
Phase: N/A
Study type: Interventional

Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population receiving chronic hemodialysis. The complications associated with missed or shortened dialysis sessions are serious and frequently require emergent medical care or hospitalization. Previous studies have shown that electronic messages have significantly improved attendance rates in a primary care setting, but these messages have not been validated in the chronic dialysis population. An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or phone calls to notify patients prior to each upcoming appointment, as well as alert a designated patient advocate. Patients receiving the messages are provided with key contact information for a dialysis rescheduling phone line, transportation resources, social work services, etc. They may also receive instructions on what to do if they are experiencing physical symptoms and need educational facts about dialysis. In particular, the intervention is designed to demonstrate to patients that the center cares and is concerned for their health and wellbeing. This intervention may potentially improve patient adherence to their scheduled sessions, increase patient satisfaction with their treatment, and prevent medical complications associated with missed dialysis appointments. This study aims to determine whether an electronic intervention, which sends SMS text messages or phone calls of key dialysis treatment information, is able to improve dialysis treatment session attendance among dialysis patients with a history of poor attendance. We secondarily aim to identify the factors that may be barriers to dialysis treatment session attendance and the emergency department or hospital utilization associated with missed dialysis treatments. Patients will be prospectively identified, recruited, and randomized into two groups. Group A will receive the electronic intervention prior to their appointments; Group B will not receive any electronic intervention. After 8 weeks, crossover will occur for both groups and the study will continue for an additional 8 weeks. Participants' clinic records will be reviewed to determine the numbers of missed and attended appointments, as well as records of ED visits and hospital admissions. Subjects will be asked to complete a post-study satisfaction questionnaire.

NCT ID: NCT02966028 Completed - Clinical trials for Cardiovascular Diseases

Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD