Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease
Chronic Kidney DiseaseThe substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atherosclerosis, and the strong association between elevated inflammatory biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the mortality in this population of patients is attributable to cardiovascular disease. Insulin resistance is also a common problem in uremic patients. It has been shown that insulin resistance may contribute to atherosclerotic cardiovascular disease. An intriguing observation in CKD patients with advanced uremia is that the metabolic profile of these patients is characterized by persistent low-grade inflammation, a state of insulin resistance, and significantly increased prevalence of atherosclerosis. It is possible that these metabolic derangements can be the inciting factors for development and progression of uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a ligand-activated nuclear transcription factor found in cells of the immune system and the vasculature, where it exerts an overall protective effect on the development of atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma improve not only the insulin resistance, but also have profound beneficial effects on inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the investigators hypothesize that short-term administration of a PPAR-gamma agonist (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial dysfunction in chronic kidney disease patients with advanced uremia.
Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)
Chronic Kidney DiseaseThe purpose of this study is to look at subject incidence of adverse events.
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Renal Insufficiency,ChronicBovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.
Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Diabetic Kidney DiseaseDiabetic Nephropathies8 moreThe Researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (MSC) in patients with progressive diabetic kidney disease (DKD).
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
HyperuricemiaChronic Kidney DiseasesAim 1. To determine the effect of Allopurinol treatment on renal function (glomerular filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid levels (hyperuricemia). Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury biomarkers.
The Integrated Population (I-POP) Health Trial
DiabetesHypertension3 moreThe primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.
A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is...
Chronic Kidney DiseaseNovo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level. The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function. All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day. The study will last for about 9-14 weeks. Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits. Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded. Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements. Women can only take part in the study if they cannot get pregnant.
An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease...
Chronic Kidney DiseaseType 2 Diabetes MellitusThis is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. People receiving the following CKD or T2D treatments as recommended by their doctors will be included: Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP-1 RA), Steroidal mineralocorticoid receptor antagonists (sMRA), Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) Other nsMRA (only in Japan) Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease. Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D. The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available. To do this, the researchers will collect data on: Patient characteristics (e.g., age sex) of the participants Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants Treatments for T2D and CKD Other medications used Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024). Researchers will also collect data on treatment patterns and changes for each type of treatment in both time periods. Health care data will be collected from various sources in six countries (e.g., Denmark, Japan, the Netherlands, Spain, the United Kingdom, and the United States). The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information. Each patient will be in the study from first use (in Study period I and II) of one of the listed drug classes until: End of study The data are somehow no longer available The patient leaves or has to leave the study
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney...
HyperkalemiaThe purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.
Guangzhou Nutrition and Health Study (GNHS)
Cardiovascular DiseasesOsteoporosis11 morePurpose: The Guangzhou Nutrition and Health Study (GNHS) project aims to assess the determinants of metabolic disease in nutritional aspects, as well as other environmental and genetic factors, and explore possible mechanisms with multi-omics integration. Study design: GNHS is a community-based prospective cohort study. Participants: In this cohort, the original GNHS and another cohort study (the controls of a case-control study of hip fractures, CCFH) have been integrated into the one GNHS project. After completing the baseline examination, a total of 5118 participants were recruited during 2008-2015 in the GNHS project. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, dual-energy x-ray absorptiometry (DXA) scanning, ultrasonography evaluation, vascular endothelial function evaluation, cardiopulmonary exercise testing, magnetic resonance imaging (MRI), 14-d real-time continuous glucose monitoring tests, laboratory tests, and multi-omics data were/will be conducted. Up to December 2022, 3442 and 2895 subjects completed the 2nd and 3rd visits. Key variables: Questionnaire interviews. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, muscle function and bracelet motion monitoring. DXA scanning: To determine bone density, bone mineral content, bone geometry information, fat mass, and muscle mass. Ultrasonography evaluations: To determine carotid artery intima-media thickness and plaque, and fatty liver. Vascular endothelial function evaluation. Cardiopulmonary exercise testing: Lung function. MRI: Brain and upper-abdomen MRI. 14-d Real-time continuous glucose monitoring tests. Specimen collections: Overnight fasting blood, early morning first-void urine, faces, and saliva samples. Laboratory tests: Metabolic syndrome-related indices; Diabetes-related indices; Uric acid; Nutritional indices; Inflammatory cytokines; Index of oxidative stress; Adipocytes; Sexual hormones; Liver and renal function-related markers; Routine blood test. Multi-omics data: Genotyping data; Gut microbiota; Untargeted serum and fecal proteomics; Targeted serum and fecal metabolomics. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.