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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05800444 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants

Start date: April 3, 2023
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The 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 work properly. The study treatment BAY3283142 is under development for treating 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. The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure: - The average highest level of BAY3283142 in the blood (also called Cmax) - The average total level of BAY3283142 in the blood (also called AUC). Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The study doctors will look at the results from these participants and then decide whether to increase the amount of the study treatment in the next group of participants. Researchers use dose escalation studies to learn about the safety of a specific amount before participants are given a higher amount. Participants will be in the study for up to 7 weeks, including an in-house stay of up to 15 days. One test (screening) visit to the study center is planned before the start of treatment and one follow-up visit is planned after the end of treatment. During the study, the study team will: - check vital signs - do physical examinations - take blood and urine samples - examine the participants' heart health using electrocardiogram (ECG)

NCT ID: NCT05797506 Recruiting - Clinical trials for Chronic Kidney Disease Stage 3

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

The Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.

NCT ID: NCT05793346 Not yet recruiting - Pregnancy Related Clinical Trials

Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool

PREDICT
Start date: March 2023
Phase:
Study type: Observational

To develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study.

NCT ID: NCT05793138 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Dialysis Geriatric Care Model

Start date: May 16, 2024
Phase: N/A
Study type: Interventional

The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.

NCT ID: NCT05786482 Active, not recruiting - Cancer Clinical Trials

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

EMPOwer
Start date: February 12, 2023
Phase: N/A
Study type: Interventional

Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

NCT ID: NCT05784389 Recruiting - Kidney Diseases Clinical Trials

Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

REMA-CKD
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.

NCT ID: NCT05783960 Recruiting - Clinical trials for Chronic Kidney Diseases

External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.

UniverSel
Start date: July 16, 2023
Phase:
Study type: Observational

There is no validated self-questionnaire to assess salt and potassium intake in nephrology patients. Using Bayesian models, researchers developed clinical prediction tools to estimate salt and potassium intake in nephrology patients. These prediction tools performed well, with an accuracy of 89% for salt and 74% for potassium, and have undergone internal validation. Currently, the investigators wish to conduct an external validation study of these clinical prediction tools using data from patients followed at 3 nephrologic centers to generalize the performance results of the tools.

NCT ID: NCT05781334 Recruiting - Heart Failure Clinical Trials

Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease

IMPLEMENT-CRM
Start date: June 9, 2023
Phase: N/A
Study type: Interventional

This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.

NCT ID: NCT05780086 Recruiting - Clinical trials for Chronic Kidney Diseases

Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution

Start date: February 3, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis

NCT ID: NCT05774392 Not yet recruiting - Clinical trials for End Stage Kidney Disease

An Observational Study of Patients With Chronic Kidney Disease

Start date: May 2023
Phase:
Study type: Observational

TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).