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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00586261 Terminated - Clinical trials for Chronic Kidney Disease

Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function

Start date: March 2006
Phase: N/A
Study type: Interventional

The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.

NCT ID: NCT00586131 Completed - Clinical trials for End-stage Renal Disease

Arterial pH and Total Body Nitrogen Balances in APD

Start date: September 2003
Phase: Phase 4
Study type: Interventional

This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.

NCT ID: NCT00583973 Completed - Inflammation Clinical Trials

Effect of Parenteral Iron Therapy on Inflammatory Response and Oxidative Stress Chronic Hemodialysis

Start date: January 2007
Phase: N/A
Study type: Observational

Parenteral iron therapy is now commonly administered to dialysis patients with the majority of patients receiving this therapy as part of the treatment for their anemia. Although intravenous iron has improved clinical response to recombinant erythropoietin, there is a concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD) patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative stress. Numerous in vitro studies have shown tissue toxicity from iron and increased infectious potential. Oxidative stress can also lead to activation of the systemic inflammatory response with the release of a number of key cytokines and growth factors. There is now a link between inflammation, oxidative stress and acceleration of vascular disease in both patients with normal as well as reduced renal function. In a study comparing normal versus low hematocrit levels in hemodialysis patients, mortality was higher in the normal hematocrit group. The major difference between the two groups has been attributed to the fact that patients in the normal hematocrit group received significantly more iron than the patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients receiving parenteral iron. The effect of parenteral iron administration on activation of the systemic inflammatory response in hemodialysis patients has not been evaluated. The purpose of this study is to measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis patients receiving iron repletion therapy as part of their standard care.

NCT ID: NCT00581269 Terminated - Clinical trials for Chronic Kidney Disease

Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and inflammation has been identified in all stages of CKD, ranging from moderate renal insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and inflammation associated with the development of CKD is currently poorly understood. There is also concern about the epidemic of obesity in the United States, as the overall health status of the general population is adversely affected by increasing adiposity. Recent studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor for progression to ESRD, even after additional adjustments for baseline blood pressure and the presence or absence of diabetes mellitus. Limited data in the general population show that healthy lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative stress has not been investigated in the obese CKD population. Based on the foregoing observations, the purpose of this investigation will be to determine whether healthy lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of life.

NCT ID: NCT00576602 Terminated - Anemia Clinical Trials

A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant

Start date: December 2007
Phase: Phase 4
Study type: Interventional

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00576303 Completed - Anemia Clinical Trials

A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

Start date: February 2008
Phase: Phase 3
Study type: Interventional

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00575497 Completed - Clinical trials for Chronic Kidney Disease

More Frequent Dialysis (>3 Treatments Per Week)

MFD
Start date: January 2005
Phase: N/A
Study type: Interventional

The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.

NCT ID: NCT00574808 Completed - Stroke Clinical Trials

Improved Delivery of Cardiovascular Care Through Outreach Facilitation

IDOCC
Start date: April 2007
Phase: Phase 1
Study type: Interventional

The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation Model, in which skilled health professionals known as facilitators (Practice Change Consultants) serve as an expert resource to primary care practices in three areas: a) practice performance assessment, feedback, and consensus building towards goal setting and implementation; b) clinical, technical, organizational resources and practical advice; and c) encouragement to face and move through the challenges associated with implementing system change.

NCT ID: NCT00572663 Completed - Clinical trials for Chronic Kidney Disease

Optimalization of Nephroprotection Using N-Acetylcysteine

Start date: January 2005
Phase: N/A
Study type: Interventional

The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

NCT ID: NCT00572312 Completed - Clinical trials for Chronic Kidney Disease

Optimalization of Nephroprotection Using Atorvastatin (Sortis)

Start date: February 2005
Phase: N/A
Study type: Interventional

The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.