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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00566670 Completed - Clinical trials for End Stage Renal Disease

Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease

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

National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress. The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.

NCT ID: NCT00565396 Active, not recruiting - Proteinuria Clinical Trials

Effectiveness Study on Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3

FLIP
Start date: September 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.

NCT ID: NCT00563355 Completed - Clinical trials for Cardiovascular Diseases

A Study to Evaluate Whether Correction of Anemia Using Recombinant Human Erythropoietin Reduces the Progression of Atherosclerosis and Cardiac Hypertrophy in Pre-dialysis Chronic Kidney Disease Patients

Start date: February 2001
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate the effects of correction of anemia using erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in patients with chronic kidney disease

NCT ID: NCT00561093 Completed - Inflammation Clinical Trials

Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

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

Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients

NCT ID: NCT00560014 Completed - Clinical trials for Chronic Renal Disease

Nutrient Levels Alter Transplant Outcome

Start date: September 1997
Phase: N/A
Study type: Interventional

The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.

NCT ID: NCT00559767 Completed - Clinical trials for End Stage Renal Disease (ESRD)

Mapping of End Stage Renal Disease Genetic Susceptibility in African Americans by Admixture Linkage Disequilibrium

Start date: June 30, 2006
Phase: N/A
Study type: Observational

This study will identify which regions on the genes, and genes themselves, may account for an increased risk of end stage renal disease (ESRD), that is, near-total loss of kidney function, for people of African American descent. Researchers will use a technique called admixture linkage disequilibrium (MALD) to study genomes, genetic material, in about 2,500 participants from two existing studies and participants who will serve as controls. ESRD disproportionately affects African Americans, who constitute 29% of all ESRD patients in the Medicare ESRD program. The disease can result from a variety of diseases, with diabetes as the leading underlying cause (44% of cases) and hypertension as the second leading cause (26%). The proportion of ESRD cases caused by diabetes has increased dramatically. Patients age 18 and older who are African American, who have ESRD, and who are participants of the FIND and CHOICE studies may be eligible for this study. FIND, or Family Investigation of Diabetes and Nephropathy, involves a multicenter study to identify susceptibility genes, that is, those with a risk, for diabetic and other forms of kidney disease. CHOICE, or Choices for Healthy Outcomes in Caring for ESRD patients is an ongoing study that identifies risk factors for cardiovascular outcomes in ESRD patients. The principle of mapping by MALD involves genetic variations that exist across populations. When mixing occurs between populations having different (heterogeneous) genes, the admixed offspring inherits chromosomes of distinct ancestry. However, over generations of mating, and recombination over several generations, originally large blocks of DNA from African ancestry have become part of smaller segments throughout the chromosome. The study will focus on risk alleles, that is, alternative forms of genes that carry a disease risk. Risk alleles are closely related to nearby ancestral gene markers found in a person. Patients will undergo a collection of blood and urine for genetic testing. Researchers are conducting separate analyses in this study. Case-control analysis of ESRD will consist of 1,150 participants from FIND and 250 from CHOICE. There will also be 750 control participants from FIND. For the case-control analysis of diabetic ESRD, there will be about 750 participants from FIND, 125 from CHOICE, and 750 controls from FIND. Finally, there is the quantitative trait analysis, which looks at the phenotype-meaning visible characteristics produced by the interaction of a person's genetic makeup with the environment. That analysis will involve 350 patients with diabetic nephropathy but not ESRD and 750 controls from FIND.

NCT ID: NCT00559637 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or on Dialysis.

Start date: n/a
Phase: Phase 3
Study type: Interventional

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not treated with ESA and not on dialysis. Eligible patients will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00559273 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00556465 Completed - Clinical trials for Chronic Kidney Disease

Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

Start date: January 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Diabetic nephropathy has become the single most frequent cause of end-stage renal disease. On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species. Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy. Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells. N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis. Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation. N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species . Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.

NCT ID: NCT00552409 Completed - Diabetes Mellitus Clinical Trials

Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Start date: December 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each taken by mouth once daily for a study duration of one year. Study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney disease and cardiovascular risk.