Clinical Research Directory

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.

ESA Hyporesponsiveness in Hemodialysis Patients

This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.

An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347). No study drug will be given during this study.

The CPH-MBD Cohort

Persons with chronic kidney disease (CKD) have a 3-fold increased risk of bone fracture and a 10-fold increased risk of cardiovascular disease than the general population. These increased risks are related to the disturbances in the mineral metabolism, and this clinical entity is termed Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD). The overall aim of the present project is to explore factors that may predict or associate with the development of bone and cardiovascular disease in patients with CKD and hopefully provide insight into underlying mechanisms and pathophysiological pathways for future treatment and prevention. In a sub study investigators aim to explore the calcium and phosphate balance in patients with CKD and describe how these associate with each other as well as with kidney function (eGFR).

Escitalopram and the Risk of Serious Adverse Events

The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 10mg/day of Escitalopram (higher dose) compared to 5 mg/day (lower dose) in adults over the age of 65 with low kidney function. Primary question Whether initiating a new outpatient prescription of a higher dose of Escitalopram (10mg/day) compared to a lower dose (5 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk of a composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality?

Citalopram and the Risk of Serious Adverse Events

This population-based cohort study aims to evaluate the safety of initiating a new outpatient prescription of citalopram at 20 mg/day (higher dose) compared to 10 mg/day (lower dose) in adults aged 65 years and older with reduced kidney function. The primary research question is whether initiating a higher dose of citalopram (20 mg/day) versus a lower dose (10 mg/day) in older adults with low kidney function (defined as an estimated glomerular filtration rate \[eGFR\] less than 45 mL/min per 1.73 m2, without dialysis or a history of kidney transplantation) is associated with an increased 30-day risk of a composite outcome comprising all-cause hospitalization, all-cause emergency department visits, or all-cause mortality.

Pramipexole and the Risk of Serious Adverse Events

This is a population-based cohort study assessing whether initiation of a higher dose of pramipexole (0.25 or 0.375 mg/day), compared with a lower dose (0.125 mg/day), in older adults with advanced chronic kidney disease (CKD) (an estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m² but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk of a composite outcome of all-cause hospitalization or all-cause emergency visits, or all-cause mortality.

Domperidone and the Risk of Serious Adverse Events

This study will assess whether initiating domperidone at doses ≥30 mg/day compared to \<30 mg/day in patients with advanced chronic kidney disease (CKD) (estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m² but not receiving dialysis) is associated with a higher 30-day risk of a composite outcome of all-cause hospitalization or all-cause emergency visits or all-cause mortality.

Lorazepam and the Risk of Serious Adverse Events

This is a population-based cohort study assessing whether initiating a new outpatient prescription of a higher dose of lorazepam (\>1-4 mg/day) compared to a lower dose (0.5-1 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) is associated with an increased 30-day risk of a composite outcome, including all-cause hospitalization, all-cause emergency visit, or all-cause mortality.

Tamsulosin and the Risk of Serious Adverse Events

This is a population-based cohort study assessing whether initiating a higher dose of tamsulosin (0.8 mg/day) compared to a lower dose (0.4 mg/day) in older adults with advanced chronic kidney disease (CKD) (an estimated glomerular filtration rate (eGFR) \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 90-day risk of a composite outcome of all-cause hospitalization or all-cause emergency visits or all-cause mortality.

Sertraline and the Risk of Serious Adverse Events

The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney function. The primary question is whether initiating a new outpatient prescription of a higher dose of Sertraline (50mg/day) compared to a lower dose (25 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2, but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk. The outcome measured will be a composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?

The impact of the environment on health is becoming an increasingly important issue in public health policies. Endocrine disruptors (EDs) are substances or mixtures of substances found in many everyday products that interact with the body's endocrine functions. Although their mechanisms of action are not yet fully understood, mechanisms involving endocrine mimicry, antagonism, and epigenetic effects have been described. The effects of the main endocrine disruptors on bone health remain poorly understood. Per- and polyfluoroalkyl substances (PFAS) constitute a large family of synthetic organic compounds used for their non-stick and heat-resistant properties. Perfluorooctanoic acid (PFOA) is a specific PFAS compound used in packaging materials and plastics. One of the known effects of PFAS is their interference with vitamin D through competition at its receptor, thereby reducing bone formation. In addition, PFAS decrease the proliferation of bone cells and reduce extracellular matrix synthesis. From foetal development through adolescence, early life represents a critical period for bone formation. If environmental chemicals can interfere with this process in the general paediatric population, the accumulation of endocrine disruptors may also exert an additional deleterious effect in the context of chronic kidney disease-mineral and bone disorder (CKD-MBD). Indeed, patients with chronic kidney disease (CKD) have a higher incidence of fractures and present mineral, skeletal, and cardiovascular abnormalities whose pathophysiology is extremely complex. The potential impact of endocrine disruptors on the pathophysiology of CKD-MBD in children has never been evaluated, despite the fact that during dialysis sessions, blood repeatedly circulates through a circuit composed mainly of plastics and exposed to elevated temperatures. In adult dialysis populations, PFAS exposure has been investigated, but the results are contradictory. In 2018, Liu et al. found no evidence of PFAS removal by haemodialysis. Conversely, studies by Liu et al. (2018) and Huang et al. (2023) demonstrated a significant reduction in PFAS concentrations in patients following haemodialysis sessions and compared with patients with chronic kidney disease not receiving dialysis. Both research groups suggested that PFAS levels in dialysis patients are significantly influenced by the composition and properties of the dialysis membranes used. However, these studies were conducted exclusively in adults, who, by definition, do not have a growing skeleton, and were restricted to PFAS measurements. This is particularly relevant given that: (1) dialysis techniques are rapidly evolving, with hemodiafiltration increasingly replacing conventional haemodialysis and with different membrane types used in paediatric practice; and (2) children undergoing dialysis often require more frequent treatment sessions than adults. For example, according to the French national survey conducted on January 28, 2026, in preparation for discussions on a new dialysis reimbursement model, 25% of the 93 children receiving chronic haemodialysis underwent treatment more than three times per week. Furthermore, none of these studies assessed the impact of peritoneal dialysis, a modality that is relatively uncommon in adults but widely used in paediatrics, particularly among very young children. These considerations have prompted us to evaluate PFAS serum concentrations in children with: (1) chronic kidney disease, (2) peritoneal dialysis, and (3) haemodialysis. This study is designed as a pilot project that may support the development of a larger-scale investigation depending on the results obtained.

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure

Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR \< 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease \& presenting with decompensated heart failure has not yet been explored fully.

Patient-centered Precision Medicine Lab Result Communication for Older Adults

For adults ≥65 years and their providers, the investigators will test the usability and design of a tool to replace standard uniform reporting of lab results to patients and their providers with a new personalized Electronic Health Record (EHR) lab result communication tool that: 1) extracts patient-level data from the EHR; 2) calculates individual risk; and 3) for patients with very low risk, communicates the individualized risk information. The investigators will employ a range of User Experience (UX) research methods to understand how patient and provider users interact with the new lab result communication tool and to assess their comprehension of the lab results. This study will be conducted with both patient and provider participants. The patient participant portion of this study uses a four-arm, design to evaluate three newly designed laboratory result communication template reports compared with the current standard (control) communication. The provider participant portion of this study is non-randomized; all provider participants will review all four template reports. This will include live semi-structured interviews with the participants and review of the template report(s) of the Chronic Kidney Disease (CKD) lab result communication tool. An anonymous in-person template report feedback survey will be provided to the participants to gauge their understanding of the template report(s), clarity of the information presented, and overall satisfaction with the tool. This will be a single-visit interaction with the participant in the UCLA Health geriatric or general medicine patient waiting room. The survey was revised after an initial pilot.

Epidemiological Cluster Evaluation in Patients Admitted to Internal Medicine, With at Least One of the Following Diagnoses: Heart Failure, COPD, Renal Failure. The FADOI IN-CluDiMI Study

Improved medical care has led to an increase in both the age and clinical complexity of patients admitted to Internal Medicine wards, characterized by multiple chronic diseases. Multimorbidity is a common issue in the elderly, significantly associated with higher mortality, functional decline, and poorer quality of life. The concept of "disease clustering" goes beyond simple multimorbidity or comorbidity by grouping statistically associated morbid conditions to understand their interconnections, shared risk factors, and pathophysiological mechanisms. The goal is to identify these clusters in relation to the most common chronic conditions in Internal Medicine: heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease.This is an observational, multicenter, prospective, national study sponsored by the FADOI Foundation (Federation of Associations of Internal Medicine Hospital) and this is a non-profit research project. It aims to involve about 50 Internal Medicine Units, targeting the enrollment of approximately 100 consecutive adult patients per unit, for a total of at least 1500 subjects per pathology group.

Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

Chronic kidney disease may progress to end-stage renal disease, a stage in which the kidneys will no longer be able to adequately remove extra fluid and waste products from the body. Many patients with end-stage renal disease will require regular dialysis to survive. Conventional hemodialysis is the most commonly used dialysis technique and will mainly remove waste products through diffusion. Hemodiafiltration is another dialysis technique that will combine diffusion with convection and may help remove a wider range of waste substances from the blood. This randomized clinical trial will compare hemodiafiltration with conventional hemodialysis in adult patients with end-stage renal disease who are already receiving maintenance dialysis. Eligible participants will be assigned by random allocation to either conventional hemodialysis or hemodiafiltration. Both treatments will be provided as part of routine dialysis care, and no experimental drug will be used. The main purpose of the study will be to determine whether hemodiafiltration will lead to better fluid control compared with conventional hemodialysis. Fluid control will be assessed by measuring the average weight gained between dialysis sessions over a four-week period. The study will also compare selected blood test parameters between the two groups after one month, including hemoglobin, C-reactive protein, serum albumin, total cholesterol, serum calcium, serum phosphate, and intact parathyroid hormone.

Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

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.

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

Kidney Awareness Registry and Education

The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.

A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)

The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation. Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA. The study is looking at several other research questions, including: * Side effects that may be experienced from taking vonsetamig * How vonsetamig works in the body * How much vonsetamig is present in the blood * If vonsetamig works to lower levels of antibodies to HLA

Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength

The aging Veteran population has more frequent inpatient hospitalization than non-Veterans. In addition, older Veterans have an inability to fully recover muscle mass and function after hospital-acquired weakness. The problem of hospital-acquired weakness is greatly increased in at-risk Veteran populations such as those with chronic kidney disease (CKD). The purpose of this collaborative study involving Denver and Baltimore VAMC sites is to improve health through the detection and rehabilitation management of hospital-acquired weakness in those with CKD. The study goals include identifying and monitoring the optimal muscle assessment sites in clinical settings, examining how muscle health impacts length of hospital stay and physical resilience, and determining how home-based and supervised exercise comparatively addresses post-hospitalization physical resilience using performance tests and Veteran feedback.

Multimedia Health Education on Physical Fitness and Physical Activity for Patients With Chronic Kidney Disease

This clinical trial aims to determine whether a multimedia educational intervention can effectively improve physical fitness and physical activity levels in patients with chronic kidney disease (CKD), while also evaluating its overall outcomes. The study primarily seeks to answer the following questions: * Can multimedia education enhance CKD patients' cardiorespiratory endurance, muscle strength, flexibility, and physical activity levels? * Do patients receiving multimedia education demonstrate greater improvements in health behavior and fitness compared to those receiving standard education alone? Researchers will compare a multimedia educational video program with conventional patient education to assess whether the multimedia approach helps patients maintain regular exercise and improve physical performance. Participants will: * Be randomly assigned to either the multimedia education group or the standard education group. * Take part in a 12-week intervention and assessment period. * Undergo pre- and post-intervention evaluations, including: * Six-minute walk test, grip strength and chair-stand test, flexibility test, and body composition analysis (BMI, waist-to-hip ratio, InBody). * Completion of a physical activity questionnaire (IPAQ-C). The findings will be used to evaluate the clinical value of multimedia education in CKD management and to support the development of effective patient exercise education programs.

Multifrequency MRE in Evaluation of Chronic Kidney Diseases

Chronic Kidney Disease (CKD) is a major public health issue, leading to high mortality and the necessity for renal replacement therapy. Kidney fibrosis, resulting from chronic damage to kidney tissue, significantly determines CKD outcomes. Kidney biopsy, the gold standard for assessing fibrosis, is invasive and limited in its ability to reflect the heterogeneous nature of fibrosis. Consequently, there is growing interest in noninvasive methods, particularly Magnetic Resonance Elastography (MRE). MRE, which evaluates tissue stiffness, has shown potential for assessing kidney fibrosis. This study aims to use multifrequency MRE to assess renal fibrosis, focusing particularly on the early stages of CKD, to enhance understanding of its progression and relationship to clinical outcomes.

Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.

DOVE-MET-COME-100 is a single site prescreening survey study designed to identify adults who may be eligible for future industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, current health conditions and symptoms. The study team may also collect basic health information, including vital signs, urine drug tests, blood samples and pregnancy tests (if applicable). A physician will review each participant's medical history in a one-on-one interview to assess potential fit for upcoming trials. If needed, the doctor may contact the participant's current doctors or pharmacies to gather more information for eligibility review.