View clinical trials related to Renal Insufficiency, Chronic.
Filter by:A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functional vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. To date, VA dysfunction is the major cause of morbidity and hospitalisation in HD patients, and the major limitation of HD treatment. The current recommendation for VA is the native artero-venous fistula (AVF), surgically created in the forearm, but is still affected by high non-maturation and early failure rates. The most common cause of AVF early-failure is vascular stenosis due to neointimal hyperplasia (NH). Despite the exact mechanisms underlying stenosis development remain tentative, there is general consensus that hemodynamic conditions play a key role in the formation of NH. Previous computational fluid dynamics (CFD) investigations inside patient-specific AVF models conducted by our group revealed transitional laminar-to-turbulent flow in the juxta-anastomotic vein. Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF. The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow. VasQ attempts at constraining and shaping geometrical parameters of the AVF, as well as reinforcing the vulnerable perianastomotic vein against high pressure, wall tension and flow levels. A prospective single-centre study demonstrated the safety of the VasQ external support device, but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated. A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI (NCE-MRI) and high-resolution CFD simulations, using a NCE-MRI protocol recently optimized by our group. Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition. Combined with high-resolution CFD, our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints, immediately after AVF surgery and at AVF maturation. Therefore, it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions, as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device.
This is a data collection study to compare diagnostic methods of a prototype of a home monitoring device against laboratory testing in the hospital.
The Pathways Collaborative is the first attempt to implement supportive (palliative) kidney care at multiple sites in the United States. While supportive kidney care is growing in other countries, notably Canada, Australia, and Great Britain, it is not yet known how to integrate it into the unique nephrology environment in the United States. In Phase 1 of Pathways (completed), we developed an evidence-based change packet of 14 best practices for integrating supportive care practices into the continuum of care for patients with end stage kidney disease (ESKD). In Phase 2 (described in this application), we will conduct a learning collaborative to help up to 15 dialysis and CKD centers implement these best practices. The learning collaborative is based on the IHI Collaborative Model for Achieving Breakthrough Improvement. This model is a tested systematic approach to quality improvement designed to help organizations close the gap between current and future practice based on evidence-based best practices. The Pathways Project faculty will work with up to 15 change teams at dialysis centers to create a system to identify seriously ill patients with kidney disease; conduct conversations with them so that their values, preferences, and goals for current and future medical treatment are known and respected; assess and address patients' physical, psychological and spiritual needs; and coordinate care throughout the healthcare system so patients receive only the care they want in settings in which they wish to be.
An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease.
This study will evaluate providing fruits and vegetables in a sustainable community care clinic setting, in addition to routine medical care, to individuals with CKD (Stage 2-4) on CKD and CVD risk, or cardio-renal risk factors. Further, metabolomics profiling will be used to study how change in the diet affects disease risk. Data from this study will be published in peer-reviewed journals, presented at national conferences, and will serve as pilot data to guide and strengthen applications for NIH funding.
Cardiovascular disease (CVD) is prevalent in patients with chronic kidney disease (CKD) and is associated with extremely poor prognosis. Traditional risk factors for the general population, such as diabetes mellitus, high blood pressure, and dyslipidemia, are more common in patients with CKD but cannot fully explain the increased risk of this population. New evidence suggests that the uremic milieu itself plays a critical role in the development and progression of CVD. The gut microbiota is markedly altered in CKD, with overgrowth of bacteria that produce uremic toxins. Indoxyl sulfate (IS) is among the most representative gut‐derived uremic toxins and has been most frequently implicated as a contributor to the pathogenesis of CVD in CKD. IS is converted from indole, a gut bacteria metabolite of dietary tryptophan, by two hepatic enzymes, CYP2E1 and SULT1A1. The majority of studies have assessed IS toxicity in cultured cells and animal models. However, human data have been conflicting and the benefit of using orally administered adsorbents to reduce IS levels in unselected CKD patients was not supported by results from the recent randomized controlled trials. IS levels may fluctuate widely from time to time with dietary intakes. The investigators hypothesize that a postprandial IS concentration may more reflect its toxicity than a single time point (fasting or predialysis IS) concentration measured in clinical studies. Therefore, the investigators plan to establish an oral tryptophan challenge test (OTCT) by using an oral loading of 2 gm tryptophan to simulate the postprandial increase of plasma IS. The investigators will recruit 60 healthy volunteers to undergo OTCT. A pharmacokinetic study of IS after the OTCT will be performed in 20 of them to verify and simplify the design of OTCT protocol. The results of OTCT will be integrated with whole metagenome analysis of fecal microbiota and genetic polymorphism analysis of CYP2E1 and SULT1A1 to explore the mechanisms of IS production. In addition to the known genes in microbe produces indoles, other supporting bacteria or genes will be examined by using metagenomic shotgun sequencing data.
A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
Aim and background: This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD. Methods: Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study. During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter. Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured. Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries. Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.
The individual course of chronic kidney disease (CKD) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (eGFR) decline are needed. Recently, urinary dickkopf-3 (DKK3) has been proposed to predict eGFR decline in patients with CKD, independent of presence of albuminuria. The investigators sought to examine the association between changes in DKK3 levels and eGFR decline in patients with heart failure (HF).