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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT06107166 Completed - Clinical trials for Cardiovascular Diseases

Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease

Start date: June 1, 2018
Phase:
Study type: Observational

Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.

NCT ID: NCT06094920 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial

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Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to determine the feasibility of remote clinical trial conduct in patients with type 2 diabetes and elevated albuminuria. The main questions it aims to answer are: - What is the feasibility (and advantages) of remote clinical trial conduct with multiple medications in patients with type 2 diabetes and elevated albuminuria? - What is the individual response to the SGLT2 inhibitor empagliflozin in urine albumin-creatinine ratio? - What is the individual response to the SGLT2 inhibitor empagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose? - Can suboptimal treatment responses to empagliflozin be overcome by the addition or substitution with finerenone? Participants will collect all study data in the comfort of their own environments - First-morning void urine samples - Capillary blood samples - Blood pressure - Body weight Participants will be assigned to a 3-week treatment period with empagliflozin 10 mg/day. Based on the albuminuria response after 2 weeks, participants will be allocated to one of three treatment regimens after the 3-week treatment period with empagliflozin: - Continue empagliflozin for 4 more weeks (good response). - Continue empagliflozin for 4 more weeks and add finerenone 10 or 20 mg will be added for 4 weeks (moderate response). - Stop empagliflozin and start finerenone 10 or 20 mg for 4 weeks (no response)

NCT ID: NCT06094231 Recruiting - Diabetes Mellitus Clinical Trials

Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the Sodium-Glucose-Transporter-2-Inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus. Participants will be randomized 1:1. The interventional group will be educated on how to implement a therapeutic carbohydrate restriction (50-100 grams of carbohydrates per day). Regarding safety, the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters. The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus. Both groups will be treated with dapagliflozin.

NCT ID: NCT06089057 Not yet recruiting - Clinical trials for Lower Extremity Muscle Strength

Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease

Start date: July 1, 2025
Phase: N/A
Study type: Interventional

This is a pilot trial of a 16-week physical activity and power training program among 30 Veterans/arm with advanced chronic kidney disease. The trial aims to test whether the program is tolerable to Veterans.

NCT ID: NCT06087835 Recruiting - Clinical trials for Chronic Kidney Disease With High Proteinuria

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

NCT ID: NCT06083545 Enrolling by invitation - CKD Stage 4 Clinical Trials

The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease

NCT ID: NCT06083168 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project

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

This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.

NCT ID: NCT06071143 Recruiting - Clinical trials for Chronic Kidney Diseases

Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease. The aim of this study is to evaluate the safety and preliminary efficacy of KDSTEM Inj. in the treatment in Patients with Chronic Kidney Disease.

NCT ID: NCT06071065 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the impact of clinical pharmacist interventions on treatment outcomes, health-related quality of life (HRQoL),and medication adherence among chronic kidney disease patients. Pharmacist's intervention aim to answer: 1. How a clinical pharmacist intervention program impact medication adherence in chronic kidney disease? 2. To assess how patients' counseling and medication adherence impact patient health-related quality of life? 3. How a clinical pharmacist intervention program improves clinical outcomes of chronic kidney disease patients?

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.