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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00312871 Terminated - Anemia Clinical Trials

Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency

Start date: February 2001
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.

NCT ID: NCT00308971 Completed - Clinical trials for Chronic Kidney Disease

Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Start date: March 2006
Phase: Phase 2
Study type: Interventional

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.

NCT ID: NCT00308490 Completed - Clinical trials for Anemia in Chronic Renal Disease

Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

Start date: September 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.

NCT ID: NCT00307814 Completed - Anemia Clinical Trials

A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)

Start date: January 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.

NCT ID: NCT00304148 Active, not recruiting - Clinical trials for Renal Insufficiency, Chronic

SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

CRIC
Start date: July 2003
Phase:
Study type: Observational

Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy. The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.

NCT ID: NCT00298129 Completed - Diabetes Mellitus Clinical Trials

Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease

Start date: February 2004
Phase: N/A
Study type: Observational

Many patients with chronic renal disease show a loss of the nocturnal decline of blood pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate 24-hour blood pressure in patients with chronic renal disease using an ambulatory blood pressure monitoring device (A & D TM2425). We also analyze the power spectrum of heart rate variability as an index of autonomic cardiovascular modulation using the same device.

NCT ID: NCT00291720 Completed - Clinical trials for Cardiovascular Disease

Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?

Start date: April 2005
Phase: Phase 2
Study type: Interventional

Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

NCT ID: NCT00285467 Completed - Clinical trials for Secondary Hyperparathyroidism in Chronic Kidney Disease Stage 3 and 4

Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Stage Three and Four

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

The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in muscle strength, blood pressure, renal function, and quality of life measures.

NCT ID: NCT00285298 Completed - Clinical trials for Kidney Failure, Chronic

Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk for progression to end-stage renal disease. The investigators hypothesize that therapy with Pentoxifylline will slow progression of kidney disease over time.

NCT ID: NCT00279084 Active, not recruiting - Clinical trials for Chronic Kidney Disease

NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels

Start date: January 2004
Phase: N/A
Study type: Interventional

In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use, control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake restriction, smoking cessation. Correcting anaemia in these patients may prevent impairment of renal function. International guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct an interventional randomized trial to evaluate the potential benefit of an haemoglobin level of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a Cockcroft's creatinine clearance of 25 - 60 ml/min.