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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05705271 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus

Start date: February 8, 2023
Phase: Phase 4
Study type: Interventional

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 2 diabetes (T2D). In people with T2D, the body does not make enough of a hormone called insulin or does not use the insulin well enough. Insulin's role is to regulate the amount of glucose (sugar) in the blood. Too much blood sugar can cause damage to the kidneys over time. Consequently, CKD can happen as one of the complications of T2D. The study treatment finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of the mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Finerenone is already available in several countries for doctors to prescribe to people with CKD and T2D. In addition, it was recently approved in India with a request to specifically gather information on finerenone therapy in Indians. The main purpose of this study is to learn how safe finerenone is in Indian people with CKD and T2D. For this, the researchers will count the number of participants who have: - medical problems after taking finerenone - abnormal high levels of potassium in the blood (called hyperkalemia). Researcher will also count the number of participants in whom hyperkalemia: - leads to stop of finerenone treatment - requires treatment to filter wastes and water from the blood - leads to a hospital stay. Doctors keep track of all medical problems that happen in studies, even if they do not think the medical problems might be related to the study treatments. In addition, the study team will collect more data about how well finerenone works in Indian people with CKD and T2D under real world setting. Working well means that the treatment can prevent the following from happening: - reduced kidney function over a period of at least 4 weeks - death from renal problems - death due to conditions affecting the heart and blood circulation - heart attack (blocked blood flow to the heart) - hospital stay due to a condition which occurs when the heart does not pump blood as well as it should - changes of the albumin and creatinine levels in urine. The participants will be in the study for approximately 20 months. They will take the study treatment once daily as a tablet by mouth for 18 months. In the study, 9 visits to the study site are planned. During the study, the study team will: - take blood and urine samples - do physical examinations - check the participants' overall health - do pregnancy tests - examine heart health using electrocardiogram ECG - check vital signs. About 30 days after the participants take their last treatment, the study doctors and their team will check worsening of reported underlying diseases: - damage to the blood vessels in the tissue of the retina at the back of the eye, as a result of diabetes mellitus - a long-term condition where the heart does not pump blood as well as it should with symptoms such as shortness of breath, tiredness and ankle swelling - heart attack (blocked blood flow to the heart) - death due to conditions affecting the heart and blood circulation or - hospital stay.

NCT ID: NCT05705011 Completed - Clinical trials for Cognitive Impairment

Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.

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

This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ]. The main question[s] it aims to answer are: - What determines the time to initiate dialysis? Cognitive impairment or frailty? - What does predict the time to death? Presence of frailty or cognitive impairment? - What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?

NCT ID: NCT05703880 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

FIRST-2
Start date: June 1, 2023
Phase:
Study type: Observational

This is an observational study, in which data from people in the United States (US) with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving finerenone treatment as prescribed by their doctors. To do this, the researchers will collect data on: - general information of the participants such as age or gender - any other disease or medical condition in the participants - other medications used while taking finerenone. The researchers will also collect data on kidney function and possible heart problems to find out how well finerenone works. Additionally, medical problems possibly related to finerenone treatment will be collected to learn more about how safe finerenone is in real-world use. The data will come from US databases Optum Electronic Health Records (EHR) and OM1 Real-World Data Cloud (RWDC). They will cover the period from July 2021 to May 2023. Only already available data is collected and studied. There are no required visits or tests in this study.

NCT ID: NCT05703620 Recruiting - Heart Failure Clinical Trials

REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

RESURRECT
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)

NCT ID: NCT05700851 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

Immuno-nutrition Supplementation in Haemodialysis

Start date: September 27, 2022
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body's defence [immune] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.

NCT ID: NCT05699109 Completed - Clinical trials for Chronic Renal Failure

Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

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

This observational study aims to compare long-acting darbepoetin alpha versus short-acting epoetin alpha erythropoietin-stimulating agents in Egyptian hemodialysis patients. The main questions aim to answer are: - What are the effectiveness and safety of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients? - What is the cost-effectiveness of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients? Participants will be divided into 2 groups; epoetin alfa (short-acting ESA), Eprex group, and darbepoetin alfa (long-acting ESA), Aranesp group for six month study period.

NCT ID: NCT05698420 Completed - Depressive Disorder Clinical Trials

Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients

Start date: March 1, 2020
Phase:
Study type: Observational

In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

NCT ID: NCT05696028 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Comparison of Different Gfr Measurements in Chronic Kidney Diseases

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

Comparison of different Gfr measurements in Chronic Kidney Diseases

NCT ID: NCT05694169 Recruiting - Clinical trials for Chronic Kidney Diseases

A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Start date: July 11, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

NCT ID: NCT05692388 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Mixed-Methods Study of Multidimensional Adversity in Inner-City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Start date: January 23, 2023
Phase:
Study type: Observational

The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing multidimensional adversity (MDA) and living in the inner-city.