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Kidney Diseases clinical trials

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NCT ID: NCT06354829 Not yet recruiting - Kidney Diseases Clinical Trials

Medical Images Collection Research

MEDICALBUM
Start date: April 2024
Phase:
Study type: Observational

This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.

NCT ID: NCT06343727 Not yet recruiting - Frailty Clinical Trials

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: - To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. - To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. - To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.

NCT ID: NCT06291116 Not yet recruiting - Kidney Diseases Clinical Trials

Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease

ETERNAL-PKD
Start date: January 1, 2025
Phase: Phase 2
Study type: Interventional

Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions. Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h). Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels. This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact.

NCT ID: NCT06291077 Not yet recruiting - Kidney Diseases Clinical Trials

Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>

BELAFENDO
Start date: January 1, 2025
Phase: Phase 4
Study type: Interventional

Kidney transplantation is the standard treatment for patients with end-stage renal failure. However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction. Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage.

NCT ID: NCT06287073 Not yet recruiting - Clinical trials for Kidney Disease, Chronic

JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)

Start date: April 30, 2024
Phase:
Study type: Observational

The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice. The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.

NCT ID: NCT06243731 Not yet recruiting - Kidney Failure Clinical Trials

A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

Start date: May 30, 2025
Phase:
Study type: Observational

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis). In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

NCT ID: NCT06223750 Not yet recruiting - Clinical trials for Kidney Disease, Chronic

Virtual Kidney Check and Follow-up

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are: - To identify chronic kidney disease in First Nations adults in Manitoba - To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category - To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure Participants will be randomized to: 1. Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio 2. Patient and primary care network contact via mail with a letter but no laboratory requisition The primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.

NCT ID: NCT06186843 Not yet recruiting - Hypertension Clinical Trials

Plant-based Diet for Kidney Transplant Recipients

Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows: - To test the feasibility of transiting renal allograft recipients who are > 3 months post-transplant to a PBD - To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients - To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients Participants will be asked to: - Complete a 2-week investigator-designed PBD transition program - Follow a PBD for a minimum of 16 weeks - Consent for blood draws, urine samples, and fecal samples along with physical exams - Complete intermittent food frequency questionnaires and quality of life questionnaires - Periodically meet with investigators and other study participants Researchers will compare baseline measurements with future measurements for each participant.

NCT ID: NCT06089473 Not yet recruiting - Frailty Clinical Trials

Virtual Home-based Multimodal Physical Pre-habilitation in Kidney Transplant Candidates

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this RCT is to address the feasibility to conduct a multimodal physical pre-habilitation intervention in kidney transplant candidates. The main questions it aims to answer are: - estimate the proportion of screened patients who meet eligibility criteria - estimate the proportion of eligible patients who consent to randomization - estimate the proportion of patients who adhere to the interventions - estimate follow-up completion rates - inform the calculation of sample size requirements for a full-scale RCT - assess the acceptability of the intervention by the participants. The 12-week virtual home-based supervised exercise program and 5-month maintenance phase with independent home exercises will also include nutrition, education, and psychological support. Participants in the control group will receive usual outpatient care.

NCT ID: NCT06069518 Not yet recruiting - Clinical trials for Diabetes Mellitus Type 2

Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis

Start date: November 1, 2023
Phase:
Study type: Observational

Background: The patient presenting Chronic Kidney Disease, with etiology of diabetes mellitus (DM), has a metabolic alteration characterized by an elevation of glycemia and accompanied by cardiovascular complications, this increases the morbidity and mortality associated with the disease. Therefore, it is necessary to maintain adequate metabolic control to reduce the incidence of these complications. This task is extraordinarily difficult without the use of Icodextrin due to the optimal adjustment of insulin, due to the additional supply of glucose contained in the Dialysis Bosas and which is absorbed through the peritoneum. Under this premise, it is of utmost importance the surveillance of the patient through constant glycemic monitoring to provide an overview of the metabolic status of our patients, this will allow clinically relevant data to improve care, minimize expenses in the health system and implement measures for decision making in the adjustment of dialysis treatment. Objective: To use continuous glucose monitoring to detect whether the type, dose, route of administration and timing of insulin application are associated with the patterns provided by continuous glucose monitoring (magnitude and duration of periods of hyper and/or hypoglycemia) in 24-hour periods of tissue glucose. Material and methods: This is a cross-sectional, non-interventional study in adult patients with Type 2 Diabetes Mellitus on Peritoneal Dialysis in its Automated modality who present high and high average peritoneal transport type. As inclusion criteria, participants over 40 years of age, of any sex, diagnosed with Diabetic Nephropathy, and who are insulin-dependent for metabolic control, with at least three months of PD treatment. The project will consist of evaluating the patient's glycemic control continuously, with an automatic scan and data recording every six hours during the infusion time of Automated Peritoneal Dialysis. For this, 110 patients are required according to the sample size. The Guardian TM 3 Sensor will be placed using the One PressTM Grafter subcutaneously in the upper posterior region of the patient's non-dominant arm, it is a minimally invasive procedure that does not require surgical protocols. This sensor will be connected to the Guardian Connect Transmitter for continuous communication with the Guardian™ Connect (App). The sensor has an approximate life of 7 days (time that lasts the enzymatic reaction and that allows an adequate measurement) the data will be transmitted every five minutes 24 hours a day, for 7 consecutive days. The patient will be scheduled at the end of these days to place a second sensor and complete the 14 days of follow-up. On day seven, the patient will be scheduled for sensor removal, and a new one will be placed to complete 14 days of follow-up. On day 14, the total 24-hour PD drainage volume will be recovered for a glucose, urea and creatinine measurement and peritoneal glucose absorption, D/P creatinine and Kt/V will be calculated. The dietary information will be obtained for the calculation of calorie intake and meal time; it is together with the subcutaneous application of insulin will be recorded within the same GuardianTM Connect (App). Statistical analysis: The databases will be audited in monthly periods by random sampling in blocks of 5% of their content. Semi-annual reports will be integrated with the monitoring of the records achieved and the outcomes to date of the reports. The reports will contain the basic descriptive information (central tendency and dispersion) according to the characteristics of the variables. Patients will be classified according to the time of glucose measurements within the pre-established ranges (70-180 mg / dL), the goal is that 70% of the time they are in that range and will be called "Adequate" and those who do not reach the goal will be called "Not Adequate". The results will be reported with measures of central tendency and dispersion appropriate to the characteristics of the variables. For the detection of difference between the appropriate and inappropriate group, the Chi square statistic or the Student's T or Mann-Whitney U will be used according to the type of variables. For the association analysis that allows detecting the variables of greatest influence on glycemic control in the recommended ranges with continuous glucose monitoring, logistic regression analysis will be used. In a first stage, analysis will be done by independent variable and in a second stage, a multivariate analysis will be made, where the type of insulin, the route of administration, the dose and the schedules will be considered. At this stage, confounding variables will also be included, such as; obesity, adherence to treatment and diet and physical activity prescribed by the treating physician.