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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00636389 Completed - Clinical trials for Chronic Kidney Disease

Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers

Start date: February 2008
Phase: N/A
Study type: Interventional

The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device. The objectives of this study are: 1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and, 2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.

NCT ID: NCT00636077 Completed - Clinical trials for Chronic Kidney Disease

Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis

Start date: February 2008
Phase: N/A
Study type: Interventional

The purposes of this study are to determine if the performance of a dialyzer depends on how tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane packing density) and if that dependence is a function of the dialysate flow rate. The study will examine how efficiently three different sized molecules pass through a dialyzer membrane at different dialysate flow rates in dialyzers with different membrane packing densities. Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be measured during clinical hemodialysis using four different dialyzers, each used at three different dialysate flow rates. The data derived from these measurements may provide insight into the importance of membrane packing density as a design parameter for hemodialyzers and if changing the membrane packing density might provide equivalent performance at a lower dialysate flow rate.

NCT ID: NCT00633646 Completed - Clinical trials for Chronic Kidney Disease

Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients

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

Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.

NCT ID: NCT00632125 Completed - Clinical trials for Chronic Kidney Disease

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

EPO-PASS
Start date: July 2008
Phase: Phase 4
Study type: Interventional

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

NCT ID: NCT00630708 Terminated - Clinical trials for Renal Insufficiency, Chronic

Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency

SDBRAS
Start date: February 2008
Phase: N/A
Study type: Interventional

The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.

NCT ID: NCT00625820 Active, not recruiting - Kidney Disease Clinical Trials

Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria

Start date: May 2008
Phase: Phase 2
Study type: Interventional

Patients with chronic kidney disease and albuminuria are at increased risk of developing cardiovascular disease which is often associated with hypertension, left ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients also manifest a decrease in nitric oxide availability which is thought to play an important role in their progressive vascular disease. Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS), an important regulator of nitric oxide (NO) and that is a key mediator of endothelial dysfunction. Changes in nitric oxide availability are believed to contribute to endothelial dysfunction seen in chronic kidney disease and common cardiovascular disease states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an investigational oral drug that is being evaluated to determine whether it will restore NO availability, leading to beneficial effects on vascular function and ultimately positive clinical outcomes in patients with chronic kidney disease. The primary endpoint in this study is the level of albuminuria, an easily measured marker that has served as a predictor of kidney disease progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have implications to slow the disease progression as well as decreased risk of cardiovascular disease.

NCT ID: NCT00618475 Completed - Depression Clinical Trials

Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

Start date: August 2008
Phase: N/A
Study type: Interventional

Depression is second in frequency only to hypertension as a comorbid condition for End Stage Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of life, more medical comorbidities and shorter lifespan. This project represents the first known attempt at a standardized intervention for depression in ethnically diverse ESRD patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be randomly selected for screening until 80 subjects meet entry criteria and agree to be randomized. Once subjects are screened and enrolled in the study they are randomly assigned to either a treatment or wait-list control condition. After 3 months, the intervention will be completed and both groups will be reassessed. After an additional 3 months, both groups will have received the intervention and pre and post measures for both groups will be available as well as 3 month follow-up for the 1st intervention group. The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and SCID II will be utilized. The BDI will provide a self-report measure of depression. The Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles, will be administered. A quality of life measure designed specifically for dialysis patients (KDQOL-SF) will also be given as a means of measuring patient's overall coping and functioning. To better understand the patient's perceptions of their health and illness the Illness Effects Questionnaire will be administered. A demographic information sheet will be completed by the subject in which personal, ethnic, and illness information is collected. Detailed information about the subject's mental health history and treatment as well as current medications will be gathered. Data from routine dialysis laboratories (hemoglobin, creatinine, albumin, Kt/V) will be extracted from the chart. The intervention will take place in individual format while the subjects are being dialyzed. The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3 months. It will include both cognitive and behavioral skills focused on alleviating depressive affect and identifying maladaptive patterns of thought and behavior. This study would lay the groundwork for future clinical research by helping to develop a culturally competent clinical intervention and demonstrate the feasibility and effectiveness of adapting psychosocial intervention for a medically complex culturally diverse population.

NCT ID: NCT00616902 Terminated - Clinical trials for Hypertrophy, Left Ventricular

The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

PRIMO II
Start date: January 2009
Phase: Phase 3
Study type: Interventional

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

NCT ID: NCT00616278 Completed - Clinical trials for Growth Hormone Deficiency

National Cooperative Growth Study in CKD

NCGS
Start date: October 2005
Phase: N/A
Study type: Observational

The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.

NCT ID: NCT00609544 Withdrawn - Anemia Clinical Trials

Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

Start date: n/a
Phase: Phase 2
Study type: Interventional

Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders. This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.