View clinical trials related to Renal Insufficiency, Chronic.
Filter by:Aims: 1. To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients. 2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients. Method: In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.
The creatinine clearance will be measured using two consecutive 24 hour urine collections, with the objective of minimizing errors due to poor quality urine collection. The GFR will be measured by a reference method, because its estimation from blood creatinine levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and therefore creatinine production, following bariatric surgery. The method will remain the same in each center, and therefore consistent for any given patient, throughout the duration of the study. The GFR measurements will be performed after stopping any medication blocking the RAAS, and reducing diuretics for one week, with the introduction or increase of alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop RAAS-blockade (heart failure), the dose will at least be reduced for one week. This precaution is required to minimize the bias of functional renal insufficiency because the state of extracellular hydration is difficult to assess in obese subjects. Subsequent measurements of GFR will be performed in the same way. The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA, 99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is hazardous in extremely obese patients and because kidney disease favors edema formation, the simplified single injection method and the determination of plasma clearance measurement of the tracer is not reliable . Only the constant infusion method will be used to measure GFR. Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several consecutive clearances. Because correct urine collection is key for the procedure, seven collection periods (instead of 5 usually) will be performed for the calculation of the mean clearance. Bladder catheterization will be used only when it can be anticipated that the patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore, this might occur exceptionably in the study. Raw data from each center will be sent to the coordination center (Nice) to examine and validate the calculation of mean clearance values. To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7 periods will be taken into account to calculate the mean values. For instance, in the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on average 4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min. Primary assessment will be performed at one year, as a previous study has already suggested a significant benefit within this period [66], and because surgery can't be delayed further in these patients strongly expecting the intervention, but follow-up will be extended to three years or until the end of the study, in order to document whether the initial benefits of surgical intervention are maintained. - A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is expected in the first six months after surgery (M0 - M6). However, the weight loss may allow an increased in mGFR indexed to body surface area up until M6, and above all towards M12. - the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in the control group who remain in a state of glomerular hyperfiltration. All relevant cardiovascular, metabolic and nutritional parameters necessary to study the risk/benefit ratio of the intervention will be analyzed. - Primary: bariatric surgery slows the progression of chronic kidney disease in the obese. - Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic, nutritional and inflammatory parameters, quality of life, and access to transplantation in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could be a chance loss for the patients in delaying surgery by one year.
The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body. The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.
Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.
Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.
Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces proteins levels associated with vascular calcification (osteoprotegerin, osteopontin, osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.
The proposed pilot study challenges the current widespread paradigm of discontinuing loop diuretics when initiating chronic HD and/or maintaining the dialysate at a constant temperature of 37 °C for all patients.
ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to improve management of patients with a triad of Chronic Kidney Disease, hypertension and diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform created by Parkland Center for Clinical Innovation(PCCI). The primary objective is to test the hypothesis that a collaborative model of primary care and subspecialty care intervention enhanced by Pieces and practice facilitators compared to standard clinical practice will reduce all-cause hospitalizations in patients with coexisting chronic kidney disease, diabetes and hypertension. Secondary objectives are: a)Test if implementation of the collaborative model will reduce 30-day readmissions, emergency room visits, cardiovascular events or deaths and disease-specific hospitalizations; b) Develop and validate risk predictive models for disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency room visits, cardiovascular events and deaths for patients with chronic kidney disease, diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data including Acute Kidney Injury, progression of chronic kidney disease, electrolyte disturbances and medication errors, and drug toxicity; e) Collect resource utilization information including hospitalizations, emergency room visits, outpatient visits, and diagnostic or therapeutic procedures completed. Candidate patients in selected clinics will be enrolled over a period of 2 years and followed for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC), Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security Index (SSI) data.