Kidney Disease

The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month. In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited. The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema. Key Question for this first study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema? This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.

Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease. Patients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study. Patients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research.

Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential Non-communicable Diseases (PEN) Plus intervention using the Interactive Systems Framework (ISF) and then implement and monitor the impact. The ISF framework proposes and organizes several implementation strategies to achieve Evidence Based Implementation (EBI) adaptation. We will apply these strategies at 2 first level hospitals (Peri-Urban and Rural) to ensure local adaptation and work towards scaling up of the WHO-PEN Plus in the rest of Zambia. This process will be inclusive, involving a Stakeholder Consultation Group that shall include the Zambian Non-Communicable diseases and injuries (NCDI) Poverty Commission and shall report bi-annually to a Project Advisory Board (PAB) chaired by the Permanent Secretary of the Ministry of Health.

The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

This study examines the efficacy and safety of Bushen Huoxue Simiao formula for tonifying the kidneys and promoting blood circulation in treating postoperative complications of upper urinary tract stones, thereby providing evidence-based medical evidence and treatment strategies for clinical practice.

Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated. This prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis. The primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.

Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.

* Rationale: Glucose control in patients with kidney disease is challenging, as traditional metrics can be unreliable and there is a high risk of hypoglycemia (low blood sugar). Although RT-CGM has shown benefits in other groups, its efficacy in patients with advanced kidney damage needs to be validated to improve their quality of life and prevent disease progression. * Main objective: To determine whether the use of RT-CGM is more effective than usual care (capillary blood glucose monitoring with a glucometer) in maintaining patients within an optimal glucose range (70-180 mg/dL) over a three-month period. * Study population: We plan to include 30 patients over 18 years of age with type 2 diabetes and chronic kidney disease (with a glomerular filtration rate less than 60 ml/min), who use insulin and are not on renal replacement therapy such as dialysis. * Methodology: The study is a randomized clinical trial consisting of two phases: 1. Selection period (15 days): Blinded monitoring is performed to obtain baseline data. 2. Treatment period (90 days): Patients are divided into two groups: the intervention group, which will use the CGM-RT with alarms configured for high and low levels, and the control group, which will continue with traditional fingerstick monitoring. * Metrics to be evaluated: In addition to time in range, researchers will analyze episodes of hypoglycemia and hyperglycemia, glycemic variability, glycated hemoglobin (HbA1c) levels, and device accuracy. * Ethical and logistical considerations: The study complies with international and national regulations, guaranteeing the confidentiality and autonomy of the participants. The project has a 24-month timeline and a detailed budget to cover medical personnel, monitoring sensors (Sinocare i3), and laboratory tests.

The goal of this clinical trial is to learn whether a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, is safe and can help improve kidney function in adults with chronic kidney disease (CKD). In this condition, the kidneys gradually lose their ability to filter blood as well as they should. The main questions it aims to answer are whether AdiaVita plus glutathione improves kidney function better than control treatments, as measured by blood tests for estimated glomerular filtration rate (eGFR) and creatinine levels, and whether the treatment is safe with acceptable side effects. Researchers will compare three groups. One group will receive AdiaVita plus glutathione. A second group will receive glutathione plus a placebo for AdiaVita. The third group will receive placebos for both treatments. A placebo looks like the real treatment but contains no active ingredients. This will help determine if the full treatment works better than the controls. Approximately 100 adults aged 18 to 80 with stage 2 to 4 chronic kidney disease may participate. Participants will be randomly assigned to one of the three treatment groups. They will receive monthly intravenous infusions at the clinic for the first three months and apply a skin spray twice daily at home during that period. The study lasts 12 months total for each participant, with regular visits for blood tests, physical exams, and safety monitoring. Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This is a single-blind study, meaning participants will not know which treatment they receive. Participant safety is closely monitored by the research team and an independent board throughout the study.

Background: Randomized clinical trials (RCTs) are essential for evaluating intervention effects but are often challenged by regulatory and logistical burdens, high costs, and extended timelines. To address these challenges, the 'Adaptive Platform Trial in Kidney Disease' (APT-KIDNEY) will establish an investigator-initiated platform trial built on a unified regulatory, contractual, and operational framework. The platform emphasizes adaptive, cost-efficient methodology, automated data capture via linkage to electronic health records and administrative registers, and stakeholder engagement. Objectives: The primary objective of APT-KIDNEY is to establish an adaptive platform trial for evaluation of multiple interventions in patients with advanced kidney disease as defined by an estimated glomerular filtration rate \< 30 ml/min/1.73 m2 or end-stage kidney disease (ESKD) on dialysis or conservative care. Study design: APT-KIDNEY is a pragmatic, randomized, embedded, multifactorial, adaptive platform trial with interventions organized into domains, emphasizing low-intervention comparisons. Domains may be open-label or blinded and will be able to use response-adaptive randomization, adaptive stopping and arm-dropping, and adaptive enrichment to enhance efficiency and relevance where applicable. Study population: Adults (≥18 years) with advanced kidney disease defined by eGFR \< 30 mL/min/1.73 m2 for ≥3 months or ESKD on hemo- or peritoneal dialysis who are eligible for ≥1 one domain. Key exclusions include inability to provide informed consent; domain-specific exclusions may apply, but eligibility cannot be broadened beyond the core protocol. Trial outcomes: Core outcomes will be all-cause mortality, major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death), and health-related quality of life (EQ-5D-5L). Abbreviated methods: APT-KIDNEY will permit domains to use frequentist and/or Bayesian methods. Primary analyses will target prespecified primary estimands and be conducted using the full analysis set. Prespecified sensitivity analyses will assess robustness to alternative strategies for intercurrent events and missing data, including per-protocol and as-treated supportive analyses. Outcomes are analyzed with generalized linear/mixed models and time-to-event methods with covariate adjustment. Frequentist analyses will be fixed-sample or group-sequential; results will be reported with 95% CIs and p-values, and Bayesian analyses will report posterior effects with 95% credible intervals and posterior probabilities. Bayesian domains will primarily use neutral, mildly skeptical priors. Multiplicity will be controlled at the domain level by a prespecified hierarchy: primary comparisons will precede secondary outcomes. Advanced adaptive domains will be evaluated by simulation to quantify operating characteristics including, power and Type I error, and the impact of outcome delays and missing data. Perspectives: APT-KIDNEY will establish an enduring, investigator-led platform for pragmatic, embedded nephrology trials, reducing start-up time and administrative burden through a shared regulatory and operational framework. Using standardized core outcomes and automated follow-up via electronic health records and national registers, it will generate faster, comparable, practice-relevant evidence across multiple interventions.

The overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start.

This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.

This is a first time in Asia (FTIA) study of GSK4771261 in healthy participants of Chinese, Japanese, and White/European ancestry. The study will test whether GSK4771261 is safe, well-tolerated, how it is processed in the body, and whether it triggers an immune response.

The objective of this study is to evaluate the effects of red propolis on inflammation and oxidative stress in patients with chronic kidney disease on conservative management.

The purpose of the study is to evaluate prospectively the impact of an electronic health record (EHR) alert on primary care providers' (PCP) referral to Nephrology of Geisinger patients with high risk signs (blood and protein in the urine) of glomerulonephritis. This will help quantify the relative effectiveness of EHR alerts on PCPs' referral patterns.

This study aims to help researchers better understand health conditions and develop improved tests, treatments, and cures for diseases. Joined Bio collects health data, lifestyle information, biological samples, and feedback from participants and provides this to qualified research partners.

The goal of this observational study is to learn more about how genes impact the risk of kidney disease. Anyone 18 or older living in the US is eligible, and a diagnosis of kidney disease is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.

This study investigates how sex hormones affect kidney function in people undergoing gender-affirming hormone therapy (GAHT). We know men have a faster progression of kidney disease. Earlier studies suggest that the female sex hormone estradiol may have a protective effect on kidney function while the male sex hormone testosterone may have the opposite effect. But the reasons why this happens remain unclear. By studying participants undergoing (GAHT) we gain insight into the mechanisms by which testosterone and estradiol influence the kidneys. People undergoing GAHT provide a unique chance to study how sex hormones interact with the kidneys. The results may help us to understand why men and women exhibit differences in kidney disease development. This study will include 30 men and 30 women, aged 18 to 40, who start GAHT. Participants will have three study visits, two of which will happen during their scheduled healthcare appointments. During the first visit, a screening will take place to check if patients can take part in the study. At study visits before and after one year of therapy, kidney function is measured, kidney MRI is performed, urine is collected and a small sample of fat tissue. Taking part in the study does not delay the start of GAHT.

The goal of this observational study is to learn about renal and hepatic blood flow abnormalities detected by bedside ultrasound in adult patients admitted to the intensive care unit (ICU) following major trauma. The main questions it aims to answer are: * How reliably can trained operators measure renal Doppler and venous congestion scores (RDRI and VExUS) across different hospitals? * How common are abnormal kidney and liver blood flow patterns in major trauma patients during the first 72 hours of ICU admission? * Are these abnormal patterns associated with acute kidney injury or the need for mechanical ventilation? Participants admitted to ICUs or high-dependency units (HDUs) with major trauma (Injury Severity Score \>15) will undergo non-invasive bedside ultrasound assessments at admission and at 24, 48, and 72 hours. No additional treatments or interventions will be given as part of this study. Kidney function will also be checked at 6 months after hospital discharge.

To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.

This study evaluates whether a digital patient education program can improve adherence to KDIGO 2022 dietary recommendations (low sodium and optimal protein intake) among patients with type 2 diabetes and chronic kidney disease (eGFR 30-59 ml/min).

The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are: Is it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease? What is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty? Researchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone. Participants will: Continue with their usual transplant assessment process If randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)