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Kidney Insufficiency clinical trials

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NCT ID: NCT01767883 Completed - Clinical trials for Chronic Kidney Disease

Improving Evidence-Based Primary Care for Chronic Kidney Disease

Start date: July 1, 2011
Phase: N/A
Study type: Interventional

Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary care offices and primary care physicians are generally not familiar with treatment guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated with co-morbidities that make effective treatment difficult due to complexity of care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective, evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality improvement and other interventions such as CDS plus practice facilitation may be needed. Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice guidelines that PCPs may use to enhance the care they provide to a difficult to manage segment of the healthcare population. Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model of practice change, versus CDS alone. The study aims to analyze differences in promoting evidence-based care in primary care practices. Thirty-six practices will be recruited for this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing over three or more months. A process evaluation will be conducted between the CDS practices with facilitation and the CDS only practices to assess clinical outcomes of CKD progression and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism starting on 07/01/2011 and ending on 06/30/2016.

NCT ID: NCT01083849 Completed - Clinical trials for Secondary Hyperparathyroidism

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

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Start date: March 2008
Phase: N/A
Study type: Observational

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

NCT ID: NCT00905619 Completed - Clinical trials for Kidney Insufficiency, Chronic

Cognitive Impairment in Kidney Disease

Start date: December 1, 2006
Phase: N/A
Study type: Observational

An increasing number of Veterans are anticipated to develop chronic kidney disease (CKD) and require hemodialysis (HD) treatments as the Veteran population ages. In 2003, approximately 290,000 US citizens were receiving HD and an estimated 19 million were affected by CKD. The annual growth rate is predicted to be 7% per year with 500,000 Americans receiving HD treatment by 2010. In 2005, approximately 2500 Veterans were receiving HD with growth expected to parallel that seen in the general population. Whereas Alzheimer's disease is the leading cause of dementia in the general population, growing evidence suggests that patients with advanced CKD experience cognitive deficits related to accelerated cerebrovascular disease. Patients with advanced CKD have been shown to have a high prevalence of sub-clinical cerebrovascular damage on imaging studies and a heavy burden of vascular risk factors such as diabetes, elevated cholesterol, and hypertension. Many of the cognitive deficits related to cerebrovascular disease may go unrecognized by routine measures of cognition. HD patients have increased number of hospitalizations, and several compliance issues ranging from congestive heart failure to dangerous electrolyte imbalances. Impaired cognition in this population is likely to have a significant impact on self-care and compliance with complex medical regimens. Currently, the severity and scope of cognitive impairment related to vascular disease is not well known in patients with advanced kidney disease. Additionally, the relationship between cognitive impairment and measures of self-care independence are not well known. Loss of independence and function secondary to impaired cognitive function is likely to be a significant problem for patients with advanced kidney disease. Early identification of functional impairment, particularly instrumental activities of daily living (IADL), will allow for rehabilitation intervention. Maintaining or improving functional independence through intensive rehabilitation could translate into better compliance and lower hospitalization rate among HD patients. Information obtained from this study is likely to heighten awareness of cognitive impairment and the functional consequences in Veterans with advanced kidney disease. Primary objectives are to determine: 1. The range of cognitive deficits with emphasis on domains affected by vascular disease in patients with advanced CKD and those receiving hemodialysis. 2. The associations between severity of cognitive impairment and severity of kidney disease. 3. The prevalence of impaired IADLs and the level of health-related quality of life (HRQOL) in patients with advanced CKD and those requiring hemodialysis. 4. The relationship or association of cognitive impairment with IADL and HRQOL. Secondary objective is to determine: 1. The relationships among cerebral and carotid blood flow, carotid artery stiffness, and renal specific metabolic abnormalities with cognitive impairment.

NCT ID: NCT00476515 Withdrawn - Clinical trials for Kidney Insufficiency

Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor

Start date: March 2007
Phase: Phase 1
Study type: Interventional

Primary Objectives: - Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful renal transplantation. - Transplant success or failure following the desensitization protocol. - Determination of the effect of rituximab on the kinetics of donor specific antibodies (DSA). - Determination of the effect of rituximab on the kinetics of B-cell subpopulations in peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of transplant, if available) in both responders and non-responders using flow cytometry and/or immunohistochemistry. Secondary Objectives: -Decrease in incidence of humoral rejection to less than 50 % at 1 year.

NCT ID: NCT00261547 Withdrawn - Clinical trials for Kidney Insufficiency

Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients

Start date: December 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if administration of rituximab blocks the development of donor specific antibodies (DSA) in transplant recipients who have developed renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production renal function will stabilize or improve.