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Kidney Failure, Chronic clinical trials

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NCT ID: NCT02314403 Completed - Clinical trials for Kidney Failure, Chronic

Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Start date: February 2015
Phase: Phase 1
Study type: Interventional

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system

NCT ID: NCT02310061 Completed - Clinical trials for Kidney Failure, Chronic

Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study).

LUST
Start date: March 2013
Phase: N/A
Study type: Interventional

Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function. Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested. The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

NCT ID: NCT02292212 Completed - Clinical trials for Kidney Failure, Chronic

Clinical Study of Asahi ViE Dialyzer in Canada

AVID
Start date: November 24, 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .

NCT ID: NCT02278159 Completed - Clinical trials for Kidney Failure, Chronic

Evaluation of the Integrated Home Dialysis Model

Start date: January 2000
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.

NCT ID: NCT02250235 Completed - Clinical trials for Kidney Failure, Chronic

Piloting an Intervention for Improving Treatment Adherence

Start date: November 2012
Phase: N/A
Study type: Interventional

Helping patient with long-term conditions to make informed decisions about adherence to their treatment is an important element in facilitating self-management. Estimates of non-adherence to treatment in people living with long-term conditions are typically high, averaging at around 50%.This not only impacts negatively on patient outcomes but also places a significant financial burden on healthcare provision. While clinical efforts have focused on promoting patient self-management, with some success, work in Psychology on behaviour change has had little influence on clinical practice. In this project, the team wish to evaluate the potential for a novel intervention from the behaviour change literature, self-affirmation, to promote improved fluid control among non-adherent patients. The intervention works by promoting a patient's sense-of-self (self-affirmation), which has been shown to modify the patient's acceptance of health-risk information, their self-efficacy, their intention to change, and subsequently their behaviour. A randomised controlled pilot trial is proposed. The trial is designed to build upon routine education about fluid control during dialysis visits, and will compare a group of patients who have received an intervention to boost their sense-of-self (self-affirmation arm) to a control group (control arm). Patients in the self-affirmation arm should have a more positive evaluation of the health-risk information about fluid management, feel more able to, and intend to change their fluid control behaviour, and subsequently have lower interdialytic weight gain.

NCT ID: NCT02235571 Completed - Clinical trials for Kidney Transplantation

iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

Start date: September 2014
Phase: N/A
Study type: Interventional

The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD. This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation. This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.

NCT ID: NCT02214563 Completed - Anemia Clinical Trials

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

CHAMBER
Start date: August 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

NCT ID: NCT02159209 Completed - Acute Kidney Injury Clinical Trials

The Drug Induced Renal Injury Consortium

DIRECT
Start date: February 2013
Phase: N/A
Study type: Observational

Some medications are known to cause kidney damage because the person is allergic to the medication while others cause direct damage to the kidney because they are toxic at certain concentrations. Risk factors for developing kidney damage have been identified for some medications but not for all. Patients who are exposed to these important medications and develop problems with their kidneys may have some genetic risk. The purpose of this study is to determine the genetic risk factors for drug induced kidney injury. A better understanding of the role of genetics for the development of kidney injury from medications will allow us to better select medications, improve effectiveness of treatment and minimize harm.

NCT ID: NCT02147977 Completed - Clinical trials for Kidney Failure Chronic

Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving Chronic Dialysis

Start date: June 2014
Phase: N/A
Study type: Interventional

Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles. Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is expressed by attenuated Heart Rate Variability (HRV) which is a measure of the variation in the time interval between heart beats. Attenuated 24 hours HRV is associated with an increased risk of sudden cardiac death in the general population and among patients with ESRD. N-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been shown to increase HRV and reduce the risk of various ventricular and supraventricular arrhythmias in some but not all studies, but this effect has only been sparsely investigated in the high risk patients with ESRD, who has a very low intake of n-3 PUFAs. Objective: The purpose of this study is to investigate the effects of n-3 PUFA supplementation on HRV and arrhythmias in dialysis patients. Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA supplementation reduces the level of Supraventricular tachycardia, premature atrial complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients. Design: Randomized double-blind, placebo controlled trial Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel Hospital, Hjørring in Denmark. Inclusion time: Summer 2014 to Fall 2015 Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs or placebo (olive oil). The following data are registered at baseline and after 3 months treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples, 48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires and blood measurements). Perspective: A positive result of this study might make it possible to achieve a reduction in arrhythmias and mortality in these high risk patients by a cheap and well tolerated nutritional supplement.

NCT ID: NCT02144285 Completed - Clinical trials for Kidney Failure, Chronic

A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis

Start date: June 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.