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Набира участници

The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients

Hypertension Obesity

Cardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Lifestyle and dietary measures, as well as pharmacological treatments, can help correct these risk factors. However, several studies have shown that even with optimal treatment, individuals at high risk still face a residual cardiovascular risk. This phenomenon is primarily attributed to the development of vascular lesions, meaning damage within the blood vessels. These lesions are largely due to inflammation, an activated immune state that is more pronounced in overweight individuals and significantly contributes to vascular damage, potentially shortening the lifespan of those with cardiovascular disease. Although anti-inflammatory therapies have proven effective in reducing this risk, they may interfere with tissue repair and the immune system. For this reason, it is essential to identify strategies that promote the resolution of inflammation without compromising these vital processes. Specialized pro-resolving mediators (SPMs) are compounds derived from omega-3 and omega-6 polyunsaturated fatty acids, which are naturally found in various foods such as fish. These mediators help limit the infiltration of inflammatory cells and initiate the repair of damaged tissues. This type of dietary supplement is already available over the counter, but its health benefits have not been extensively studied. Experimental animal studies have shown that restoring inflammation resolution through SPMs can prevent-or even reverse-cardiovascular damage and inflammation by directly acting on vascular cells and modulating the immune system. However, human data on the role of SPMs and inflammation resolution in vascular disease remain very limited. The investigators hypothesize that in individuals at high cardiovascular risk (due to obesity and hypertension), increasing circulating levels of SPMs through oral supplementation (as a dietary supplement) would improve vascular function, metabolic profile, and inflammatory and immune cell responses. In doing so, this may help reduce the residual risk of cardiovascular disease. The objective of this research is to assess whether a supplement enriched with SPMs can facilitate the resolution of inflammation, which is essential for restoring vascular function and thereby supporting the body's natural tissue repair mechanisms. To address the research question, the study plans to include 60 individuals with obesity and hypertension, all presenting a high cardiovascular risk, recruited from healthcare facilities located in France. This research is publicly funded by the French National Research Agency (Agence Nationale de la Recherche) through the European research project RESPIN-VAR, co-funded by ERA4Health and the European Union.

Начало: 26.11.2025 Край: 26.02.2027 Възраст: 18–85 г.

France Assistance Publique - Hôpitaux de Paris NCT07038252

Набира участници Фаза 2

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Muscle Invasive Bladder Urothelial Carcinoma Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

Начало: 25.11.2025 Край: 31.07.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT07061964

Набира участници Фаза 2

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

Nausea and Vomiting Caused by Chemotherapy

The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone. The main questions it aims to answer are: Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs? Participants will: Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before chemotherapy. Starting from the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct.

Начало: 25.11.2025 Край: 01.11.2026 Възраст: 18–85 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT07537699

Набира участници Фаза 1

Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes

Amputation Transtibial Amputation - Unilateral Bone Anchored Devices Osseointegration

A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.

Начало: 25.11.2025 Край: 31.05.2030 Възраст: от 18 г.

United States University of Colorado, Denver NCT07263945

Набира участници Фаза 2

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan

Nausea and Vomiting Caused by Trastuzumab Deruxtecan

The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by trastuzumab deruxtecan in breast cancer palliative therapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone. The main questions it aims to answer are: Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by trastuzumab deruxtecan? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs? Participants will: Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before trastuzumab deruxtecan treatment. Starting from the day of trastuzumab deruxtecan treatment (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct.

Начало: 25.11.2025 Край: 01.11.2026 Възраст: 18–85 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT07537673

Набира участници

Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform

Opioid Use Disorder

The study aims to adapt an existing Cultural Structural Humility (CSH) training into a video format for peer recovery coaches (PRCs) and refine an AI-driven texting tool to reinforce the training. After refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. The study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.

Начало: 25.11.2025 Край: 15.03.2027 Възраст: 18–99 г.

United States Friends Research Institute, Inc. NCT06573476

Набира участници Фаза 1

Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease

Sickle Cell Disease Executive Dysfunction Cognitive Impairment Attention Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects. The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not. Primary Objective: • Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits. Secondary Objective: • Evaluate neurobehavioral and safety outcomes following MPH treatment. Exploratory Objective: • Evaluate decision-making and determinants influencing methylphenidate utilization among parents.

Начало: 25.11.2025 Край: 01.08.2028 Възраст: 8–17 г.

United States St. Jude Children's Research Hospital NCT07226219

Набира участници Фаза 2

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel

Nausea and Vomiting Caused by Chemotherapy

The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by gemcitabine combined with paclitaxel protein-bound in pancreatic cancer treatment. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone. The main questions it aims to answer are: Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the gemcitabine plus paclitaxel protein-bound regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs? Participants will: Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before chemotherapy. Starting from the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct.

Начало: 25.11.2025 Край: 01.11.2026 Възраст: 18–85 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT07537660

Набира участници Фаза 3

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Obstructive Sleep Apnea

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.

Начало: 25.11.2025 Край: 13.09.2028 Възраст: 18–99 г. Лечение

Australia, Brazil, Canada +6 Amgen NCT07226765

Набира участници Фаза 2

A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.

Начало: 24.11.2025 Край: 01.06.2028 Възраст: 12–75 г. Лечение

Australia, Canada, Czechia +5 Kymera Therapeutics, Inc. NCT07217015

Набира участници Фаза 2

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Bipolar Disorder

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Начало: 24.11.2025 Край: 01.11.2027 Възраст: 18–75 г.

Argentina, Brazil, China +5 Eli Lilly and Company NCT07286175

Набира участници Фаза 4

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)

Obesity

The purpose of this study is to evaluate tirzepatide within a real-world setting to assess body weight loss and incidence of type 2 diabetes in adults without diabetes who have obesity and at least one weight-related comorbid condition. Participation in the study will last about 260 weeks.

Начало: 24.11.2025 Край: 01.07.2032 Възраст: от 18 г.

United Kingdom Eli Lilly and Company NCT07247084

Набира участници Фаза 1

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

Pancreatic Ductal Adenocarcinoma Non-Small Cell Lung Cancer HR+/HER2- Ductal and Lobular Breast Cancer Triple Negative Breast Cancer +2

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors

Начало: 24.11.2025 Край: 09.05.2029 Възраст: 18–100 г.

Canada, Denmark, France +2 Novartis Pharmaceuticals NCT07261631

Набира участници

Comparison of the Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients Undergoing Non-Invasive Ventilation

Respiratory Failure Critical Illness

Sedation is frequently required in critically ill patients admitted to the intensive care unit (ICU), including those receiving non-invasive respiratory support such as high-flow nasal cannula (HFNC), non-invasive ventilation (NIV), or conventional oxygen therapy. Anxiety, agitation, dyspnea, and poor tolerance of respiratory support may compromise treatment adherence and increase the risk of respiratory deterioration and endotracheal intubation. Appropriate sedation may improve patient comfort, facilitate respiratory support, and reduce complications. However, sedation in non-mechanically ventilated ICU patients remains challenging because excessive sedation may lead to respiratory depression or hemodynamic instability. Propofol is commonly used for ICU sedation because of its rapid onset and controllable depth of sedation. Nevertheless, propofol is associated with several adverse effects, including respiratory depression, hypotension, and injection pain, which may limit its use in patients without invasive mechanical ventilation. Ciprofol is a novel short-acting intravenous sedative that acts as a gamma-aminobutyric acid type A (GABA-A) receptor agonist and is structurally related to propofol. Previous studies have demonstrated that ciprofol has rapid onset, predictable sedation, less injection pain, and a potentially lower incidence of respiratory depression and hemodynamic instability compared with propofol. Clinical studies have shown favorable safety and efficacy profiles of ciprofol in procedural sedation, anesthesia induction, and sedation in mechanically ventilated ICU patients. However, evidence regarding its use in ICU patients receiving non-mechanical ventilation is still limited. This study aims to compare the effectiveness and safety of ciprofol versus propofol for sedation in adult ICU patients who are not receiving invasive mechanical ventilation. The study will be conducted as a multicenter retrospective cohort study involving approximately 30 tertiary hospitals in China. Adult ICU patients treated between January 1, 2022 and July 30, 2024 who received intravenous sedation with either ciprofol or propofol while receiving non-invasive respiratory support (including NIV, HFNC, or conventional oxygen therapy) will be included. The primary outcomes are sedation success rate and the incidence of respiratory depression. Sedation success is defined as maintaining the Richmond Agitation-Sedation Scale (RASS) within the target range of -2 to +1 for at least two consecutive hours without discontinuation of the sedation regimen or switching to another sedative. Respiratory depression will be defined based on predefined criteria including severe hypoxemia, markedly reduced respiratory rate, abnormal end-tidal carbon dioxide levels, or apnea. Secondary outcomes include endotracheal intubation rate during the sedation period, ICU length of stay, ICU mortality, and the requirement for vasoactive agents. Propensity score matching and multivariable statistical models will be used to adjust for baseline differences and potential confounders between treatment groups. This real-world study aims to provide evidence regarding the clinical effectiveness and respiratory safety of ciprofol compared with propofol for sedation in ICU patients without invasive mechanical ventilation. The findings may help optimize sedation strategies in critically ill patients receiving non-invasive respiratory support and provide evidence to support future prospective clinical trials.

Начало: 24.11.2025 Край: 30.06.2026 Възраст: от 18 г.

China Nanfang Hospital, Southern Medical University NCT07536750

Набира участници

Positioning of Children With Acute Respiratory Insufficiency

Acute Respiratory Disease

Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy. In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency. The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position. The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child. The Study Itself: Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.

Начало: 24.11.2025 Край: 01.04.2028 Възраст: до 12 г.

Denmark Odense University Hospital NCT07170085

Набира участници Фаза 3

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

Symptomatic Venous Thromboembolism (VTE)

This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. 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 * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Начало: 24.11.2025 Край: 16.07.2027 Възраст: от 18 г.

United States Regeneron Pharmaceuticals NCT07213778

Набира участници

Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

Coronary Heart Disease (CHD) Anxiety Disorders

The goal of this clinical trial is to test whether closed-loop fNIRS-BCI neurofeedback(NF) targeting the left dorsolateral prefrontal cortex(DLPFC) can reduce cardiac autonomic arousal, indexed by baseline-corrected heart rate(HR) under cold-induced pain stress, in adults with stable coronary heart disease(CHD) and comorbid anxiety. The main questions it aims to answer are: Does real left DLPFC neurofeedback, compared with sham neurofeedback, lead to a greater reduction in baseline-corrected HR during the cold-induced pain stimulation window? Does real neurofeedback produce stronger volitional upregulation of left DLPFC activation and higher inter-hemispheric synchronisation between left and right DLPFC than sham neurofeedback? Are changes in baseline-corrected HR statistically associated with, and partly mediated by, changes in left DLPFC activation or DLPFC inter-hemispheric synchronisation? What adverse events(AEs) occur during adaptive training and the formal experimental session, and do AE rates differ between the two groups? Researchers will compare a real neurofeedback group with a sham neurofeedback group to determine whether targeting the left DLPFC via closed-loop fNIRS-BCI yields superior modulation of cardiac autonomic responses and prefrontal activation patterns in CHD patients with anxiety. Participants will: undergo cardiac and psychiatric screening to confirm stable CHD, DSM-5 anxiety disorder, and other eligibility criteria; attend three adaptive training sessions(days 1-3) with fNIRS-BCI neurofeedback targeting the left DLPFC, combined with slow-wave auditory stimulation and mild cold-water exposure, while ECG is recorded; on day 4, complete one formal experimental session consisting of 15 blocks of cold-induced pain stimulation and slow-wave auditory stimulation, with simultaneous fNIRS and ECG recording, receiving either real or sham left DLPFC neurofeedback according to randomisation, and continuous monitoring for adverse events.

Начало: 23.11.2025 Край: 30.05.2026 Възраст: от 18 г.

China Shenyang Medical College NCT07244484

Набира участници Фаза 2

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

Fragile X Syndrome

This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \

Начало: 22.11.2025 Край: 01.10.2027 Възраст: 13–45 г.

United States Mirum Pharmaceuticals, Inc. NCT07209462

Набира участници Фаза 3

Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathic Pain

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).

Начало: 21.11.2025 Край: 06.04.2027 Възраст: 18–80 г.

United States Vertex Pharmaceuticals Incorporated NCT07231419

Набира участници

An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea

Chronic Kidney Disease Type 2 Diabetes Mellitus

This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied. Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D. The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D. Finerenone is a medication that works by blocking certain proteins known as 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. The main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea. The FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population. To achieve this, researchers will collect data on: * Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health. * Reasons for starting finerenone. * Reasons for stopping finerenone early. * The planned and actual duration of finerenone treatment. * The dosing of finerenone. * Other medications taken alongside finerenone. The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment. One specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to: * Early discontinuation of finerenone treatment. * The need for dialysis, a procedure that filters waste from the blood. * Hospitalization for care. Data for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits. Participants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.

Начало: 20.11.2025 Край: 28.01.2028 Възраст: от 18 г.

South Korea Bayer NCT07232537

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