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End Stage Renal Disease clinical trials

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NCT ID: NCT02019225 Terminated - Clinical trials for End Stage Renal Disease

A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

TiME
Start date: December 18, 2013
Phase: N/A
Study type: Interventional

The purpose of the TiME Trial is to determine whether dialysis facility implementation of a minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has benefits on mortality, hospitalizations and health-related quality of life. The trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial in partnership with two large dialysis provider organizations.

NCT ID: NCT01975844 Terminated - Anemia Clinical Trials

The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target Objectives: 1. Decreased variability of Hgb 2. Increase the % of patients in target range c Increase in time that Hgb remains target range

NCT ID: NCT01845012 Terminated - Clinical trials for End Stage Renal Disease

Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

HDQ200
Start date: July 2012
Phase: N/A
Study type: Interventional

HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.

NCT ID: NCT01644526 Terminated - Clinical trials for End Stage Renal Disease

A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement

Start date: January 2016
Phase: N/A
Study type: Interventional

The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding, and blood steal from the extremities. The Hemoaccess Valve System (HVS) allows an AV graft to be turned on to blood flow when it is needed for dialysis then when dialysis is concluded, the device shuts off arterial blood flow and residual blood in the graft is flushed back into the body, using the dialysis blood lines. Once the graft is cleared of blood, the venous valve is then closed. Heparinized sterile saline reside in the graft between dialysis sessions. By having only saline in the graft and restoring normal blood flow to the artery and vein, it is believed that this will dramatically reduce the current complications associated with now having blood diverted through the graft 24/7.

NCT ID: NCT01601873 Terminated - Clinical trials for End-stage Renal Disease

Propaten Randomized Investigation on Cost-benefit and Efficacy

PRICE
Start date: November 9, 2012
Phase: N/A
Study type: Interventional

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

NCT ID: NCT01555515 Terminated - Anemia Clinical Trials

Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.

NCT ID: NCT01427374 Terminated - Clinical trials for End Stage Renal Disease

Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients

Start date: May 2011
Phase:
Study type: Observational

Individuals with kidney disease are at a higher risk for heart and vascular diseases, including heart attacks and strokes, than those with normal kidney function. The purpose of this research study is to collect information on the causes, complications and treatment of kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data will be collected to examine relationships between biochemical and genetic markers and cardiovascular risk. Information on the health history of incident hemodialysis and peritoneal dialysis patients will be captured using structured patient interviews and review of medical records. Blood and urine specimens will be collected at the time of dialysis initiation and stored in order to perform novel biochemical and genetic assays in the future. The overall goal of the CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a subset of patients enrolled. The goals of the substudy are to examine whether the risks of developing common cardiac-related complications (coronary artery calcification [CAC] and left ventricular hypertrophy [LVH]) are associated with certain medications taken by individuals on dialysis and whether these risks are modified by a genotypic predisposition.

NCT ID: NCT01413074 Terminated - Clinical trials for End Stage Renal Disease

Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China

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

Primary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment. Secondary Objectives: The secondary objectives are to prospectively assess and compare the following parameters in subjects receiving PD or HD treatment: - Technique failure - Cause of death - Comorbidity status at baseline and changes throughout the study - Change in residual renal function (RRF) - Dialysis adequacy (i.e., Kt/Vurea) - Change in blood pressure, hemoglobin, and S-phosphate - Change in nutritional status - Occurrence of bacterial and other infections - Hospitalization, including number, duration, and underlying reason(s) - Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP) - Quality of life (QOL) Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious adverse events (SAEs), including abnormal laboratory test findings with clinical significance, in subjects receiving PD or HD treatment.

NCT ID: NCT01353638 Terminated - Clinical trials for End Stage Renal Disease

Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solution in Peritoneal Dialysis

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in patients suffering from end stage renal disease. However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products (GDP). Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors of the cellular stress response - the adequate HRS rather seems to be blocked. Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage and organ failure and improve the survival of organisms. Preclinical results demonstrated that supplementation of PDF with pharmacological doses of alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells in in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD. After these positive preclinical results, this study shall now clarify, whether the addition of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable. Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics and the presence/absence/severity of side effects.

NCT ID: NCT01291771 Terminated - Clinical trials for End Stage Renal Disease

Myocardial Microvascular Disease in ESRD

MICROCARD
Start date: January 2011
Phase: N/A
Study type: Interventional

Cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (>70%) is low. The goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. These patients routinely undergo non invasive detection of myocardial ischemia. Patient included in the study will be followed up for 2 years for major cardiovascular events. Patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. During coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of microcirculatory resistance (IMR). Comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.