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NCT07241390
The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.
NCT05348733
This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: * Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants * Reasons for starting finerenone * Reasons for stopping finerenone early * How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) * Dosing of finerenone * Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: * Stopping finerenone treatment too early * Dialysis (a medical procedure to filter the blood of extra water and waste) * Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.
NCT07483372
This is a single-center, open-label, exploratory clinical study designed to evaluate the safety and efficacy of a single-session injection of SC101, a small interfering RNA (siRNA) agent, into the perirenal fat. This study plans to enroll 3 participants, aged 18 to 65 years, who have a clinical diagnosis of resistant hypertension and moderate to severe chronic kidney disease (CKD).
NCT04634916
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
NCT06926660
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants are in the study for about 4.5 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine. The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT04784351
This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient's admission. This algorithm was then validated in a validation cohort.
NCT07355296
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT07271186
This study is researching experimental drugs called ALN-ANG3 and evinacumab (called "study drugs"). The study is focused on participants who have diabetic kidney disease. The aim of the study is to see how safe and effective the study drugs are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times
NCT03535922
Patient-reported outcome measures (PROMs) are reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient's responses by a clinician or anyone else. PROMs capture patients' experiences of symptoms and impact of disease on functioning and can support clinicians to monitor disease progression and facilitate patient-centered care. The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario. In this study, two kinds of PROMs will be used: a disease-specific PROM and a generic PROM. The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health. In the trial, patients will be invited to complete the PROMs, and results of the measures will be linked to treatment aids for clinicians, providing specific information on how symptoms can best be managed. These care pathways will also be available to patients not receiving PROMs. The main outcome of this study will be patient-clinician communication, which will be assessed using a questionnaire called the "Communication Assessment Tool". In addition to assessing the effect of using these questionnaires on patient-provider communication, this study will allow us to explore whether their use affects patient management and symptoms, use of healthcare services, and the overall cost of implementing these questionnaires in clinical practice. Each dialysis unit (including all patients) will be randomized to one of four study groups: 1) Patients will complete the disease-specific PROM; 2) Patients will complete the generic PROM; 3) Patients will complete both the disease-specific and generic PROM; 4) Patients will receive usual care. Clinicians (in dialysis units randomized to PROMs, groups 1-3) will receive the results of the questionnaires completed by the patients. This is intended to trigger the clinician to ask the patient about certain symptoms if any exist. All clinicians in all study groups will have access to the clinical "treatment aids", which are tools that help identify and manage certain symptoms that patients might have. For example, people with severe itching will be cared for based on a step-wise treatment algorithm. Patients will also receive a report of their questionnaire(s) results, with an explanation of what it means.
NCT07471802
The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.
NCT06717698
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.
NCT07462780
This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants. Both parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.
NCT07454174
This is a 16 week pilot study of the impact of a nutritionist led ketogenic diet (Ren-Nu) supplemented with the medical food KetoCitra on autosomal dominant polycystic kidney disease.
NCT07450820
This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)
NCT06656988
The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide (CO2) Injection prevents Major Adverse Kidney Events up to 90 days (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).
NCT04592640
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
NCT06306963
The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning.
NCT07446296
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. The main questions it aims to answer are: * Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list? * Do participants follow the exercise program and wear a physical activity tracker as asked? * Is the program safe and well tolerated? Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function: * Usual pre-transplant care with a physical activity tracker * Usual pre-transplant care plus an online exercise program Participants will: * Wear a wrist activity tracker to measure daily physical activity * Complete a one-week baseline period before being assigned to a study group * Be randomly assigned (like flipping a coin) to one of two groups * If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback * Answer questionnaires about their health, activity, and experience in the study This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
NCT03633708
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
NCT07224776
Single-center, open-label, two-stage pilot study examining the efficacy and safety of sparsentan for reducing high-grade proteinuria among patients with cancer who receive vascular endothelial growth factor inhibitors