Active clinical trials for "Kidney Diseases"

The purpose of the present study is to investigate the association between the accumulation of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as the impact of a dietetic intervention on AGE accumulation. AGE will be measured non-invasively in the skin using a technique called skin autofluorescence (SAF). The present study will be conducted in two parts: Study 1: this will be a prospective study where participants will be followed-up for up to five years. The research team will measure the accumulation of AGE in the skin using a quick (less than five minutes) and painless technique called SAF. This involves placing the forearm on a piece of equipment that shines a light on the skin and measures the amount of light that is reflected back. Participants will be asked to complete nutritional and quality of life questionnaires, measurements of weight, height, arm circumference and skinfold thickness (i.e. anthropometry), simple eyesight tests and blood tests. Study 2: observational non-randomized proof of principle study where malnourished dialysis participants will receive a dietitian supervised intensive nutritional support. Participants will be followed-up for 2 years and will receive precise oral and written instructions on how to comply with the intervention. Blood and eyesight tests, SAF measurements, anthropometry and nutritional and quality of life assessments will be conducted. In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE levels and do some additional blood tests to help us investigate the effects of AGEs on the body. If the participants agree, the investigators will also store some of the blood for future research.

Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors. Nevertheless, in literature, few studies explore and reveal the utility of testing metanephrines for the evaluation of sympathetic activity and its associated cardiometabolic complications in patients with essential hypertension.

Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.

Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences. History of chronic kidney disease and the use of a large amount of iodinated contrast for planning and procedure are among the main risk factors for the development of this complication. The present study aims to: (1) define the role of non-contrast imaging modalities in pre-procedure planning; (2) evaluate the feasibility and safety of a new TAVI technique without using iodinated contrast; (3) to determine the incidence of acute renal failure in patients with aortic stenosis and chronic kidney disease undergoing TAVI, using the new technique without contrast. The study will be divided into two stages. In the pilot phase, 25 consecutive patients with chronic kidney disease (stage ≥ 3a) will have the TAVI planning and procedure performed without the use of iodinated contrast, but with all the steps subjected to verification by the standard technique, to ensure the safety of the patient. The occurrence of the combined primary safety outcome composed of adverse clinical events within 30 days (defined by the VARC-2 criteria) in less than 20% of cases will be used to define the continuity of the study. In the second phase, 50 patients with chronic kidney disease stage ≥ 3b will be submitted to TAVI with the "zero contrast" technique. The primary outcome assessed at this stage of the study will be the incidence of AKI within 7 days after TAVI using the new technique in this high-risk population.

The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). The study will also investigate the correlation between the diuresis, functional bladder capacity and LUTS in this population. By means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop LUTS. The investigators will also evaluate the impact of LUTS on the quality of life of these patients.

Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls. Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination). Main study parameters/endpoints: The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders based on a spike (S)1 specific antibody levels of >=10 or <10 BAU/mL. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs)graded according to severity. Other secondary endpoints include longevity of the immune response at 6 months, antibody respons 28 days after a third vaccination and levels of SARS-CoV-2 specific T and B cell responses.

Context and hypothesis: The prevalence of diabetes mellitus keeps going to increase, due to the ageing of the population and the high prevalence of overweight and obesity. Thus about 5% of the French population is said to have diabetes according to the national health insurance reimbursement data estimations. 15 to 20% of diabetic patients will have a foot chronic ulcer in their lifetime. Nowadays, diabetes is still the leading cause of non-traumatic amputation in France, amputation being very often preceded by a trophic disorder. Thus, the person with diabetes has a 7-fold risk of amputation. For the year 2013, in France, incidence rates of hospitalizations for lower limb amputations and foot wounds in the diabetic population were 252/100000 and 668/100000 respectively. In an attempt to prevent the risk of foot wounds in people with diabetes, the International Working Group on the Diabetic Foot (IWGDF) has established foot grades associated with an increased risk of foot wounds. These grades are now used by health authorities to calibrate their care offer such as reimbursements for podiatry care. Chronic kidney disease is one of the major complications of diabetes. In 2013, according to data from the French registry (REIN), 4,856 diabetics started renal replacement therapy in 2016, representing 46% of the newly dialyzed population. This represents a relative risk 9.2 times higher than in the general population. The Investigators hypothesize that beyond the risk of wound, there is a link between the stage of chronic renal disease and the risk of foot ulcer grade as defined by the IWGDF. The link between chronic renal disease and this common marker of foot risk has never been studied to our knowledge. The long-term objective, beyond this study, is to improve patient pathways and thus improve the prevention of foot wounds in diabetics with renal insufficiency. This is all the more true since prevention actions in the dialysis population have already shown their effectiveness on a large scale on the risk of amputation. Protocol : All patients with a diabetes mellitus who consult diabetology and nephrology services at the Montpellier University Hospital will be included in this study. The consultation wil be the same as usual. The Investigators will ask for the history of diabetes, the history of complications, the current treatments and the Investigators will make a standardized clinical examination of feet with a foot risk gradation according to the IWGDF.The investigators will report the standard biologicals values.

Hemodynamic trends will be assessed using the device, in 100 dialysis sessions in 30 patients, who are prone to develop hypotensive episode during dialysis. Sitting blood pressures will be measured immediately prior to each hemodynamic measurement: before initiation of dialysis, every each hour and in the beginning of hypotension episode, just before the end and 10 min after the end of the treatment. Gender, age, height, weight, electrode location and blood pressure data will be entered into the device. The device will measure and calculate hemodynamic parameters on each heart beat during 60 s and provides the averaged parameters. Technology for hemodynamic measurements: The device (NICaS, NI Medical) is a noninvasive regional bioimpedance cardiac measurement and analysis system (FDA 510k clearance no. K080941, 12 June 2009). The US Food and Drug Administration indication for use of the device states 'NICaS is intended to monitor and display hemodynamic parameters in males and females with known or suspected cardiac disorders needing cardiac assessment'. SV will be measured by applying an alternating electrical current of 1.4mA at 30 kHz frequency through the patient's body via two pairs of tetrapolar sensors, one pair placed on the wrist of the nonaccess arm above the radial pulse and the other pair on the contralateral ankle above the posterior tibial pulse (Figure 1). Figure 1 : Sensor location SV is calculated by Frinerman's formula: SV¼(dR/R) - q - (L2/Ri) - (ab)/b - KW - HF [2-4], where dR is the impedance change in the arterial system as a result of intraarterial expansion during systole, R is basal resistance, q is blood electrical resistance, L is the patient's height, Ri is basal resistance corrected for gender and age, KWis the correction of weight according to ideal values, HF is a hydration factor that takes into account the ratio between R and body mass index (BMI), which is correlated to body water volume, ab is the electrocardiogram (ECG) R-R wave interval and b is the diastolic time interval. SV is automatically calculated every 20 s and is the average of three measurements obtained consecutively during 60 s of monitoring. The SV index is calculated as SV/body surface area using the Du Bois formula [11]. Heart rate is calculated from a one channel ECG and cardiac (output) index¼SV index - heart rate/1000. Using an oscillometric method, sitting systolic and diastolic blood pressure measurements were made automatically by the dialysis machine. Mean arterial pressure [2 - (diastolicsystolic)/3], cardiac power index [CPI; mean arterial pressure (MAP) -cardiac index - 0.0022 w/m2; normal range 0.45-0.85w/m2] [12, 13] and total peripheral resistance (MAP/ cardiac index - 80 dyn - s/cm5 - m2; normal range 1600-3000 dyn - s/cm5- m2) [13] will be calculated. As the device measures pulsatile flow and is blinded to constant flow, fluid removal during dialysis has no impact on measurement accuracy. This was recently validated by correlating SV to ECG measurements during hemodialysis treatments. Good correlation was maintained during treatment. Further, NICaS performance immunity to fluid reduction was demonstrated by the maintenance of correlation to ECG results throughout dialysis treatments [9]. The results are drawn on hemodynamic graphs showing the MAP (y-axis) as a function of cardiac index (x-axis); curves of total peripheral resistance index (TPRI) and CPI are displayed. Ranges for the normal population are depicted by a dotted octagon.

The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are the newest class of orally drugs for the treatment of type 2 diabetes. These drugs decrease plasma glucose levels by inhibiting its reabsorption in the proximal tubules of the kidney. They have an attractive clinical efficacy profile, including glycemic control, weight loss, and lowering blood pressure. SGLT2 inhibitors have also been reported to reduce the risk of severe adverse cardiovascular events and progression of diabetic kidney disease. SGLT2 is expressed in the kidney, while its expression in other tissues is most likely negligible or absent. SGLT2 dilates the supply vessels to the glomerulus thereby promoting hyperfiltration. In animal models SGLT2 has been shown to reduce the excretion of macular dense adenosine, which may contribute to the excessive glomerular filtration rate as a result of vasodilation of the afferent vessels. Adenosine, unlike other vascular regions, increases the tension in the walls of the vessels supplying blood to the glomerulus. The role of adenosine in humans in this regard is poorly defined, although treatment with empagliflozin has recently been shown to increase the urinary excretion of adenosine in type 1 diabetic patients with controlled hyperglycemia. Our working hypothesis is that the SGLT2 inhibitor empagliflozin may reduce the hyperfiltration of residual nephrons by increasing adenosine production, which affects the contraction of the afferent arterioles, and this effect occurs in various types of nephropathy. In addition, it has been described that SGLT2 inhibitors may affect individual parameters of calcium-phosphate metabolism, leading to changes in bone mineral density and an increase in bone resorption marker SGLT2 inhibitors also stimulate renal, proximal phosphate reabsorption. Increased phosphate reabsorption triggers the secretion of fibroblast growth factor 23 (FGF23). FGF23 inhibits the production of 1,25-dihydroxyvitamin D (the biologically active form of vitamin D), which reduces the absorption of calcium from the gastrointestinal tract, thereby stimulating the secretion of parathyroid hormone (PTH). In the conducted studies, it was found that SGLT2 inhibitors increase the concentration of serum phosphorus, FGF23 in the plasma and PTH in the plasma, while lowering the level of 1,25-dihydroxyvitamin D.