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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05471518 Recruiting - Clinical trials for Chronic Kidney Diseases

Sex Hormone and Vascular Function in Women With CKD

Start date: July 1, 2021
Phase:
Study type: Observational

The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.

NCT ID: NCT05465044 Recruiting - Clinical trials for Chronic Kidney Disease (CKD) Stage 5

Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)

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

In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.

NCT ID: NCT05457283 Recruiting - Clinical trials for Chronic Kidney Disease

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

FIONA OLE
Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: - have their blood pressure, heart rate, temperature, height and weight measured - have blood and urine samples taken - have physical examinations - have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) - answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer - answer questions about how they are feeling, or have their parents or guardian's answer - answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.

NCT ID: NCT05439980 Recruiting - Clinical trials for Chronic Kidney Diseases

Improving Phosphate Control in Children With CKD

IMPACT
Start date: June 20, 2023
Phase:
Study type: Observational

Research goals: To explore the views and baseline knowledge of children and young people (CYP) with CKD and their caregivers to develop effective phosphate educational materials (PEM), adapted for age, and acknowledging different learning styles

NCT ID: NCT05424809 Recruiting - Obesity Clinical Trials

Feasibility and Preliminary Effectiveness of a Shared Decision-making Process

Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Background: Shared decision-making is a process where health professionals and patients work together through conversation and using tools to make the best possible decision for the person. Patient decision aids provide information based on the best available evidence, support the deliberative process, and further help clarifies individual patient values and preferences. Incorporating shared decision-making in clinical practice is challenging. Hypothesis: A proposed shared decision-making implementation model is feasible and improves patients' knowledge of possible treatment options, as well as patients' perception and degree of satisfaction with the decision-making process. Objective: To evaluate the feasibility and preliminary effectiveness of implementing a shared decision-making model in a tertiary university hospital. Methods: It is proposed to carry out a pilot randomized clinical study (ratio 1:1), with two arms, in parallel, open, single center. Adult patients from two clinical processes will be included: a) Obesity (treatment options: bariatric surgery or medical management (healthy habits +/- pharmacological treatment), and b) Advanced Chronic Kidney Disease (ACKD) (treatment options: hemodialysis, peritoneal dialysis, or conservative treatment). Since it is a pilot study, the investigators estimated a random sample of between 20 to 40 participants per intervention group and control group (total sample 40 to 80 per pathology) would be needed. The intervention group will carry out the shared decision-making model, and the control group will receive the usual clinical practice with detailed information from a health professional. The primary outcomes of interest to be evaluated are a) feasibility; b) quality of the decision and the decision-making process.

NCT ID: NCT05407389 Recruiting - Clinical trials for Chronic Kidney Disease stage4

Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

Start date: April 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study

NCT ID: NCT05398783 Recruiting - Cancer Clinical Trials

A Natural History Study of Metabolic Sizing in Health and Disease

Start date: October 25, 2022
Phase:
Study type: Observational

Background: Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism. Objective: This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people. Eligibility: Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer. Design: Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet. Participants will undergo many tests: They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath. They will lie on a padded table for about 15 minutes while their body is scanned. They will stand on a platform while a 3D scanner measures their body. They will have a test to measure how fast an electric signal moves through their body. They will grip an instrument to measure the strength of their hands. They will drink salty water and provide blood and urine samples. Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.

NCT ID: NCT05395247 Recruiting - Clinical trials for Chronic Kidney Diseases

Geriatric Assessment for Older Kidney Transplantation Candidates

Start date: January 1, 2019
Phase:
Study type: Observational

Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation.

NCT ID: NCT05391451 Recruiting - Clinical trials for Chronic Kidney Diseases

New Approach of Loco Regional Analgesia in Kidney Transplant

CARRENAL
Start date: August 31, 2021
Phase: N/A
Study type: Interventional

Kidney transplant is considered as a moderate painful surgery. Unfortunately, patients with chronic kidney disease are not able to degrade opioid drugs and are therefore most likely to be subjected to the secondary effects of their consumption. Current strategies aim to find pain relief substitutes in order to decrease the use of opioids, specially after surgery, during patient recovery. Loco-regional analgesia consists of administering local anesthesic directly in specific nerves and is being used in several surgical procedures. In various abdominal surgeries, a loco-regional analgesia called "tranversus abdominis Plane Block" has been associated with decreased morphine consumption and better post-operative conditions. In kidney transplant, the definitive efficacy of this loco-regional analgesia is not established, due to controversial clinical results. The goal of our study is to test the analgesia advantage of a variant of the Tranversus Abdominis Plane Block, called Quadratus lumborum block, which targets a muscle called quadratus lumborum, in association with general anesthesia, on post-surgery recovery and opioid intake.

NCT ID: NCT05380843 Recruiting - Clinical trials for Chronic Kidney Diseases

Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

Start date: May 16, 2022
Phase:
Study type: Observational

The decision making in the Czech nephrology offices depends on the local common practice which is likely to be heterogenous. In other words, the same patient would be indicated to different therapy and regimen at different sites. To date, the practices and treatment paths have not been described. The aim of the present epidemiological research is to characterize the population of CKD patients at the point of treatment choice and to outline the motivation of nephrologist to initiate particular therapy.