Clinical Research Directory

Immune System Related Kidney Disease

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.

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

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.

Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)

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.

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)

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.

GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study

To establish a prospective, longitudinal cohort of participants who can provide blood, tissue (including kidney histology), urine samples to establish a core biobank for kidney disease research. Results from this biobank will be matched to clinical outcomes to facilitate the discovery (and/or validation) of novel prognostic, predictive or diagnostic biomarkers important for kidney disease.

A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive

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.

Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease

Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.

Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD

Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional CV risk factors. Arterial dysfunction is an important nontraditional CV risk factor gaining increased recognition in the field of nephrology. This process is best represented, both physiologically and pathophysiologically, by increases in the gold standard measure of arterial stiffening, carotid to femoral artery pulse wave velocity (CFPWV), which reflects, in particular, increases in aortic stiffness. Aortic stiffening with CKD is mediated by structural and functional (increased vascular smooth muscle tone) changes in the arterial wall stimulated by oxidative stress and chronic low-grade inflammation. Caloric restriction (CR) is a promising strategy for prevention of CKD-associated arterial dysfunction and CVD. However, long-term adherence to chronic CR regimens with optimal nutrition is very difficult to achieve. Research has shown that boosting NAD+ bioavailability to stimulate SIRT-1, a "CR mimetic" approach, reduces CFPW and oxidative stress in old mice, and this lab recently took the first step in translating these findings in a study of adults with normal kidney function and elevated systolic blood pressure (SBP). The data found that supplementation with nicotinamide riboside, a natural, commercially available precursor of NAD+ and novel CR mimetic, increased NAD+ bioavailability and reduced CFPWV and SBP. A randomized, placebo-controlled, double-blind, single-site phase IIa clinical trial to assess the safety and efficacy of oral nicotinamide riboside (500 mg capsules 2x/day; NIAGEN®; ChromaDex Inc.) for 3 months vs. placebo for decreasing aortic stiffness and SBP in patients (35-80 years) with stage III and IV CKD is being proposed. It is hypothesized that treatment will reduce CFPWV and SBP, as related to increases in systemic NAD+ bioavailability and reductions in oxidative stress, and inflammation. Aim 1: To measure CFPWV (primary outcome) before/after nicotinamide riboside vs. placebo treatment; Aim 2: To measure casual and 24h-ambulatory SBP (secondary outcome) before and after treatment; Aim 3: To determine the safety and tolerability of treatment with nicotinamide riboside vs. placebo; Aim 4: To measure systemic NAD+ and NAD+-related metabolite concentrations, as well as circulating markers of oxidative stress, inflammation, and vasoconstriction factors before and after treatment.

A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.

Urine Testing to Detect Kidney Transplant Rejection

The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

DIALysis With EXpanded Solute Removal

The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is: 1\) Does expanded hemodialysis reduce the risk of death from any cause? Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes. Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).

Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.

Introduction: Dental implants offer a durable, aesthetic, and functional option for tooth replacement. However, they are not immune to failure. Current literature has highlighted the importance of systemic factors (such as vitamin D deficiency, osteoporosis and hypercolesterolemia) and local factors (such as the presence of nearby periapical infections or implant placement in sites with a history of endodontic failure) that affect bone health. Hypothesis: Bone alterations-whether systemic or local-represent a risk factor for implant failure and peri-implantitis. Objectives: To analyze implant failure and marginal bone loss in patients with local and/or systemic bone alterations compared to patients without such conditions. Methods: Implant failures occurring in patients treated within the Master's Program in Oral Medicine, Surgery, and Implantology at the University of Barcelona (MCIO-UB) over the last 10 years will be analyzed and correlated with bone factors (local and systemic) recorded in their medical histories. Cases lacking the radiographic and clinical data necessary to conduct the study will be excluded. Population: A total of 3,500 implants have been placed, with failure rates ranging from 4% to 8% depending on the techniques used; consequently, the study sample will consist of 192 implants. Cohorts of successful implants will be established by matching patients of the same sex and within a ±5-year age range who did not experience implant failure.

Strategies to Transform Kidney Care and Improve Pursuit of Transplant

Approximately 15% of the U.S. population has chronic kidney disease, and \~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors. While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care. Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

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.

A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function

The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin). For each participant, the study will last about 14 weeks, excluding screening.

Pedal Pump Clinical Trial on Edema V1

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.

ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease

Background and aim: ABO blood groups are biologically plausible modulators of endothelial function, coagulation, and inflammation - pathways central to diabetic kidney disease (DKD). This study evaluates whether ABO/Rh phenotypes associate with differential treatment outcomes in DKD. Methods: This 1-year prospective cohort study enrolled 161 adults with type 2 diabetes and established DKD (all receiving ACE-I/ARB plus SGLT2 inhibitors) from Cairo University outpatient clinics. eGFR, ACR, HbA1c, lipids, electrolytes, and blood pressure were assessed at baseline and one year. Percent changes in eGFR and ACR were calculated and the Kidney Failure Risk Equation estimated 2- and 5-year risk of progressing to end stage kidney disease. Multivariable linear regression identified independent predictors of renal outcome changes.

Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System

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 Clinical Research of Traditional Chinese Medicine Formula

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.

Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

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).

The Effect of Patient Empowerment Learning (With AI) About Itching in Hemodylasis Patients.

This study investigates whether artificial intelligence-supported patient education can reduce itching and improve patient empowerment in individuals with chronic kidney disease undergoing hemodialysis.

A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease

This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given. Part A is testing the new study treatment on healthy people. This is to see if it's safe, what it does to the body, and how the body's defense system responds to it. Part B is similar, but the study treatment will be given to people who have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD).

Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation

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.

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

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.