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Kidney Diseases clinical trials

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NCT ID: NCT02250287 Completed - Kidney Disease Clinical Trials

New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease

MRI Pilot
Start date: December 2014
Phase: N/A
Study type: Observational

The purpose of this study is to establish normal Magnetic Resonance quantitative values (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level Determination values for both renal cortex and medullary tissues and total renal blood flow) for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function, and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and normal renal function. Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness, Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization Transfer and renal blood flow) will have different values in young adult ADPKD patients as compared to normal volunteers.

NCT ID: NCT02244801 Completed - Kidney Disease Clinical Trials

Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study )

DART
Start date: April 2015
Phase: Phase 1
Study type: Interventional

This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.

NCT ID: NCT02238067 Completed - Clinical trials for Kidney Disease, Chronic

Survey on Anemia Therapy in Patients With Chronic Kidney Disease Not on Dialysis

Start date: September 2011
Phase: N/A
Study type: Observational

This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim is to better understand the current therapy pattern for anemia in chronic kidney disease (CKD) treated with erythropoiesis-stimulating agents (ESAs) and not on-dialysis patient population in Israel. Participating physicians will be requested to complete a satisfaction survey for anemia treatment for eligible patients with CKD not on dialysis. The survey will be completed twice, once at study start and once at six months' follow-up.

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: NCT02140905 Completed - Heart Failure Clinical Trials

Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis

Start date: April 2014
Phase: N/A
Study type: Observational

The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis (ΔF) for subjects with ESRD and possibly Heart Failure. The second objective is to demonstrate correlation between ΔSFI and relative changes in impedance (ΔZ) as measured by the reference device.

NCT ID: NCT02092727 Completed - Kidney Disease Clinical Trials

The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study

RaDIANT
Start date: February 2014
Phase: N/A
Study type: Interventional

The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.

NCT ID: NCT02075879 Completed - Kidney Disease Clinical Trials

The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients

Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of a nurse-led case management programme on home exercise training for haemodialysis patients. We hypothesised that: a. There is no significant difference in physical functioning between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. b. There is no difference in depression between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. c. There is no difference in quality of life and health perception between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. d. There is no difference in physical activity levels between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. e. There is no difference in perceived benefits and barriers of exercise between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. The study was a randomized controlled trial conducted in two haemodialysis units of two tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study group or comparison group. Participants in both groups received the in-center exercise training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was focused on flexibility and strengthening exercise. Patients were encouraged to have cardiovascular exercises at home which will improve their cardiovascular conditions and endurance. The list of cardiovascular exercise included brisk walking, bicycling, jogging. Participants in the study group were instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the study group patients weekly for six weeks and biweekly for another six weeks. Participants in the comparison group only participated in the in-center exercise training. The comparison group patients received usual care from the nurse without the interviews and mutual goals developed.

NCT ID: NCT02039817 Completed - Kidney Diseases Clinical Trials

PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers

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

This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers with normal renal function.

NCT ID: NCT01991483 Completed - Clinical trials for Renal Insufficiency, Chronic

A Study of LY2928057 in Hemodialysis Participants

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. This study will last up to 26 weeks for each participant.

NCT ID: NCT01985360 Completed - Clinical trials for Coronary Artery Disease

ISCHEMIA-Chronic Kidney Disease Trial

ISCHEMIA-CKD
Start date: January 2014
Phase: Phase 4
Study type: Interventional

The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate inducible ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m² or on dialysis). This is a multicenter randomized controlled trial of 777 randomized participants with advanced CKD. Participants were assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization (if suitable) plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial as a companion trial. SPECIFIC AIMS A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive strategy of cardiac cath followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction in participants with SIHD and advanced CKD over an average follow-up of approximately 2.8 years compared with an initial conservative strategy of OMT alone with catheterization reserved for those who fail OMT. The primary endpoint is time to centrally adjudicated death or nonfatal myocardial infarction (MI). B. Secondary Aims. Major: To compare the incident of the composite of death, nonfatal MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure, and angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire, between the INV and CON strategies. Other secondary aims include: comparing the incidence of the composite of death, nonfatal MI, hospitalization for unstable angina, hospitalization for heart failure, resuscitated cardiac arrest, or stroke; composite of death, nonfatal MI, or stroke; composite endpoints incorporating cardiovascular death; composite endpoints incorporating other definitions of MI as defined in the clinical event charter; individual components of the primary and major secondary endpoints; stroke and health resource utilization, costs, and cost effectiveness. A major secondary aim of ISCHEMIA-CKD trial is to compare the quality of life (QOL) outcomes-patients' symptoms, functioning and well-being-between those assigned to an invasive strategy as compared with a conservative strategy. In the protocol, angina frequency and disease-specific quality of life measured by the Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life scales, respectively, are described as the tools that will be used to make this comparative assessment. Recent work has indicated that it is possible to combine the information from the individual domain scores in the SAQ into a new Summary Score that captures the information from the SAQ Angina Frequency, Physical Limitation and Quality of Life scales into a single overall score. The advantages of using a summary score as the primary measure of QOL effects of a therapy are a single primary endpoint comparison rather than two or three (eliminating concerns some may have about multiple comparisons) and a more intuitive holistic (patient-centric) interpretation of the effectiveness results. With these advantages in mind, the ISCHEMIA leadership has agreed that the SAQ Summary Score will be designated as the primary way this secondary endpoint will be analyzed and interpreted, with the individual SAQ scores being used in a secondary, explanatory and descriptive role. A key subgroup analysis will be to stratify the results among those with daily/weekly angina (baseline SAQ Angina Frequency score ≤60), monthly angina (SAQ Angina Frequency score 61-99) and no angina (SAQ Angina Frequency score = 100). Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III