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150 active trials for End Stage Renal Disease

Improved Selection of Elderly (> 65 Years) for Kidney Transplantation

Kidney transplantation has been shown to provide improved survival even in patients older than 70 years of age. The purpose of the study is to determine whether kidney transplantation provides any improvement of health related quality of life (HRQOL) in patients over the age of 65 years. HRQOL wil be monitored using the Kidney Disease and Quality of Life (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the Norwegian transplant wait list and followed every 6 months until transplantation. Thereafter a new form will be completed after 10 weeks post transplant, 6 months, 1 year, 3 years and 5 years. In addition the study will explore the transplant candidates expectations in a qualitative study design and explore the relationship between pre-transplant comorbidity, HRQOL and survival.

Start: December 2012

Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients

The purpose of this randomized, controlled pilot study is to evaluate the performance of this novel Anemia Controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. Since the Anemia Controller is designed to bring patients to a pre-defined Hgb target level and keep them there, the target population for this study are patients whose Hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the Hgb target range under a standard anemia management algorithm). Specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting Hgb cycling.

Start: January 2020

Far Infrared Therapy on Peritoneal Function of CAPD Patients

For patients with end-stage renal disease, peritoneal dialysis (PD) has been proven to be an alternative choice compared to hemodialysis as a type of maintenance renal replacement therapy. Despite this, long-term PD is associated with structural membrane changes that are believed to contribute to alterations in solute transport and loss of ultrafiltration. Previous studies have proven that far-infrared (FIR) therapy may improve not only the arteriovenous fistula patency in hemodialysis patients but also abdominal discomfort due to encapsulating peritoneal sclerosis in PD patients. Since there is little information concerning this issue, this study was conducted in order to evaluate the possible effects of FIR therapy on the peritoneal function of patients receiving continuous ambulatory peritoneal dialysis (CAPD). The objective of this study is to evaluate the effect of FIR therapy on the peritoneal function, protein loss, and ultrafiltration capacity of CAPD patients.

Start: January 2016

Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B

The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

Start: July 2019

Comparison of Daily Home Hemodialysis (HD) With Conventional in Center HD in Terms of Patients Quality of Life and Clinical Outcomes

The objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in France the effectiveness shown in studies, mainly American, both in terms of clinical outcomes and quality of life. Due to the few studies available in this population, the focus will be particularly on physical activity.

Start: June 2018

Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.

Start: June 2012

Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are glomerular filtration rate, daily urine volume, serum middle molecule concentrations, hospitalization, mortality, and patient reporeted outcomes.

Start: March 2020

The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients

Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.

Start: September 2019

Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices

Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.

Start: August 2019

Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis

This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.

Start: July 2018

Low Potassium Content Vegetables in End-Stage Renal Disease

Hyperkalemia is common in End-Stage Renal Disease on chronic hemodialysis patients. The most common cause of mortality in End-Stage Renal Disease patients is sudden cardiac death caused by hyperkalemia. Hyperkalemia also increased urgent dialysis and hospitalization rate. Thus, the management for hyperkalemia in End-Stage Renal Disease patients is crucial, including restricting dietary potassium, medication control, and dialysis dosage adjustment. In the ordinary diet, the significant sources of potassium are vegetables and fruit. In our study, the investigators try to find out the influence of low potassium content vegetables for serum potassium control in End-Stage Renal Disease on chronic hemodialysis patients. This study is a prospective cohort study; the investigators enroll forty End-Stage Renal Disease on hemodialysis patients and perform this study in eight weeks period. The investigators conduct a randomized, double-blind and cross-over trial for investigating the influence of low potassium content vegetables on End-Stage Renal Disease patients. The serum potassium level will record under different potassium content vegetables. The possible adverse effects of low potassium content vegetables, cardiac arrhythmia, will also obtain by chart records during this study.

Start: January 2020

Chinese Medicine on Deferring Dialysis Initiation

Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents overt clinical symptoms and is a critical stage when patients are encountered with dialysis. The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the most important dialysis-related question. As indicated by the recently published European Renal Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but greater expenditure and sometimes more harm.Renal replacement therapies (RRT) including dialysis are the most common procedures for patients with end-stage renal disease (ESRD), but conservative management should be an option in patients who still experience the stable period without clinical indications of dialysis.Chinese Medicine (CM) is recognized as an alternative therapy on alleviating uremic symptoms, deferring dialysis initiation, and improving quality of life. Although the effects of CM on kidney disease have been demonstrated in animal experiments, evidence from large clinical trial is insufficient. So we raise the hypothesis that CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern and/or Colonic administration, will defer the initiation of dialysis in adults with stage 5 CKD.

Start: July 2014

A Model of Computer-assisted Prescription of Erythropoiesis-stimulating Agents (ESA) in Patients Under Hemodialysis

This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl.

Start: July 2019

Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Start: September 2019

Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)

Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.

Start: October 2016

Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)

Start: September 2018

The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis

The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and de novo atrial fibrillation.

Start: October 2019

Explore Transplant @Home Within Kaiser Permanente Southern California

Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive regular dialysis treatments, by which waste is filtered from the blood by a machine, or a kidney transplant from a deceased or living donor. Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of ESRD patients remain on dialysis, especially ethnic/racial minorities. An American Society of Transplantation (AST) Consensus Conference recently recommended that patients in all CKD stages should have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial minorities even less likely to receive it. Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed decision-making for Black and White dialysis patients in Missouri when delivered by mail and supported through bimonthly postcards and texting. Now based at the University of California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California (KPSC), an integrated learning healthcare system providing insurance coverage and comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52% White, 15% Black, and 9% Asian; 10% Spanish-speaking).

Start: July 2018

Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients

The ESCAPE-PD (Effects of add-on SpironolaCtone to losartan versus Alone on Peritoneal mEmbrane among continuous ambulatory Peritoneal Dialysis patients) study is a randomized, open-label, single center, active-controlled clinical trial. Adults end-stage kidney disease patients 18 years or older undergoing continuous ambulatory peritoneal dialysis (CAPD) will be enrolled. A total 84 CAPD will be randomly assigned to either the combination of spironolactone and losartan (experimental arm) or losartan alone (control arm). The primary outcomes are the difference in peritoneal dialysate effluent cancer antigen-125 (CA-125) and peritoneal equilibration test (PET) indices (dialysate-to-plasma creatinine ratio, 4-hour ultrafiltration volume, and the concentration of glucose present in the solution at the start of the test). Secondary outcome measures include laboratory and mechanistic outcome measures, nutrition outcomes, health-related quality of life, physical function, clinical events, and safety profiles. Results will be disseminated to suggest a strategy to prevent the peritoneal membrane function among CAPD patients through peer-reviewed publications along with scientific meetings.

Start: October 2019

Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation

The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the construction of hemodialysis arteriovenous fistula. In this technique, the radial artery pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of this study is to compare the safety and efficacy of this technique with the traditional end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular access in hemodialysis patients. The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of maturation and patency.

Start: April 2017