View clinical trials related to Chronic Kidney Disease.
Filter by:1. To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Chinese people with renal impairment; 2. To explore the effect of dialysis on the functional changes of P-gp, CYP3A4, OATP1B and BCRP in patients with end-stage renal disease; 3. Validation of urotoxic molecules as possible biomarkers that can assess intestinal P-gp function.
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.
The goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (NGAL) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (SHPT). The main question it aims to answer is: the predictive effects of blood NGAL level on the efficacy of palicalcitol in the treatment of SHPT and the adverse reactions of vascular calcification progression. Participants will be treated with palicalcitol, followed up and undergo routine series of Chronic Kidney Disease-Mineral and Bone Disorder associated tests before and after treatment.
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.
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.
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.
The purpose of this study is to explore the effectiveness of a CKD-specific chatbot-based instant messaging support health education (CIM-SHE) program and determine its user evaluation by CKD patients. A pre- and post-study design was employed and 60 patients were invited to join a three-month program for chronic kidney disease health education; 55 successfully completed the intervention. Data were collected from April to November, 2020, using a structured questionnaire. Paired t-tests and generalized equation estimation were used to examine the intervention effectiveness and users' evaluation.
This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone. 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, resulting in high blood sugar levels that can cause damage to the kidneys. Chronic kidney disease often occurs together with / as a consequence of type 2 diabetes. SGLT2 inhibitors lower blood sugar levels by increasing sugar removal from the blood into the urine. SGLT2 inhibitors are the standard of care (SOC) treatment for CKD and T2D. SOC is the treatment that medical experts consider most appropriate for a disease. The drug finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with CKD together with T2D. Results from two earlier clinical studies called FIDELIO-DKD and FIGARO-DKD in participants with CKD together with T2D are available. These results suggest that the treatment combination of finerenone and SGLT2 inhibitors may work better than taking SGLT2 inhibitors alone. The treatment combination may further slow down a worsening of the participants' - kidney disease - heart and blood circulation health. Due to a limited number of participants treated with SGLT2 inhibitors alone however, the data from the two earlier studies does not allow to draw conclusions. The main objective of this study is to combine additional real world data from SGLT2 inhibitor users with the study data from the earlier studies to get clearer results. Before combining the data however, statistical tests need to prove that this is allowed. If this is the case, the new combined "control" data can be compared with the data from the combination treatment group from the earlier studies. This will allow the researchers to get more proof and draw conclusions of how well the treatment combination works compared to SGLT2 inhibitors alone. The real world data will come from a database called Optum. It will cover the period from January 2013 to September 2021. Only data from people who are similar to the participants of the control group of the earlier studies and meet certain criteria will be selected. Only data from the past is collected and studied. There are no required visits or tests in this study.
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
This is a double-blind, randomized, active-control study with 2-study arms-darbepoetin alfa biosimilar and Aranesp, noninferiority trial design in dialysis patients. Dialysis patients will be randomized into 1:1 ratio to receive either Darbepoetin alfa or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks. Pharmacokinetic/pharmacodynamic parameters for evaluation are assessed as per study endpoints at defined time points on all patients. During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in target range 10 - 12 g/dL.