View clinical trials related to Chronic Kidney Disease.
Filter by:Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications. The study treatment, BAY 3283142, is under development to treat CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body. In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142. The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function. For this, the researchers will analyze: - Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function. The study participants will be assigned to one of the four treatment groups based on their liver function: - Group 1: participants with mild reduction in liver function - Group 2: participants with moderate reduction in liver function - Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food. Each participant will be in the study for around 5 to 6 weeks, which includes: - a visit within 28 days of starting treatment to confirm if the participant can take part in this study - a hospital stay for 7 days during which the participant will be given a single dose of BAY3283142 and the study doctor will monitor the participant's health - a visit after 7 to 10 days of taking BAY3283142 during which the study doctor will perform a health check-up on the participant During the study, the doctors and their study team will: - check participants' health by performing tests such as blood and urine tests, blood pressure measurements, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. Access to study treatment after the end of this study is not planned. Participants with liver problems can continue taking their other prescribed medicines as usual.
Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP RRT) is a 12-week intervention that identifies hospitalized African Americans with advanced chronic kidney disease(CKD) and provides them with hospital- and community-based education, navigation and self-management support. Participants will be randomized to the iPREP RRT intervention versus enhanced usual care.
OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial. We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease. Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis [1]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD. Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed
The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.
The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.
Pain is one of the most common symptoms among patients with End Stage Renal Disease (ESRD), and often goes unrecognized or inadequately managed in hemodialysis patients. More than 50% of patients undergoing hemodialysis suffer from pain, with 75% of them being treated ineffectively due to healthcare professionals' lack of awareness of this symptom. Therefore, pain management in this population is a complex and challenging task for healthcare providers. The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders, metabolic neuropathies, in addition to typical intradialytic pain. The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment (physical activity, nutrition, and psychological support) already being implemented in various studies for these patients.
The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney failure, specifically, to ensure patients are actively involved in a shared decision making (SDM) process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide. Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff trained in communication skills and best practices. Approach 2 - Educate and Engage Plus Kidney Supportive Care Program: Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist. To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 28 chronic kidney disease clinics at 10 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment. Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience. Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework. For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, information will be reported by site managers as part of monthly progress reports. Clinic administrators, clinical providers, and staff will complete surveys before and after implementation of each approach.