Clinical Research Directory

Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.

Bisoprolol Versus Cognitive Behavioral Therapy for Stress in Patients on Peritoneal Dialysis

Patients on continuous ambulatory peritoneal dialysis (CAPD) often have chronic stress and anxiety. This pilot study compared two ways to reduce stress in adults on CAPD: cognitive behavioral therapy (CBT) and the beta-blocker bisoprolol. Each patient received one treatment for 30 days. The main question was whether either treatment lowers morning blood cortisol, a stress hormone. The study also compared changes in blood pressure, pulse rate, anxiety score, and sleep quality.

Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension

Many patients on hemodialysis have high blood pressure that does not respond to three or more drugs (resistant hypertension). This pilot study gave a low dose of spironolactone (12.5 mg once daily) for 6 weeks to adults on hemodialysis with resistant hypertension. The study measured changes in blood pressure, heart rate variability, markers of inflammation (interleukin-6 and high-sensitivity C-reactive protein), a marker of cardiac stress (NT-proBNP), and serum potassium.

Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study

Cold ischemia time, the period during which a donated kidney is kept cold outside the body between its removal from the donor and its transplantation into the recipient, is one of the main modifiable factors influencing how quickly and how well a transplanted kidney starts to work and how long it lasts. In France, kidneys are usually transported between hospitals by ambulance, car, train or plane, which exposes the graft to traffic, scheduling and coordination delays. Autonomous drones could offer a fast, dedicated and predictable alternative. A human kidney was successfully transplanted after drone transport in the United States in 2019, but no transplantation after drone transport of an organ has yet been reported in Europe. The RAfALREIN study is a pilot study designed to assess the safety and feasibility of transporting deceased-donor kidneys by autonomous drone between the Centre Hospitalier Départemental Vendée in La Roche-sur-Yon (procurement site) and Nantes University Hospital (transplantation site), within a dedicated medical air corridor subject to authorisation by the French civil aviation authority. Five adult patients will receive a kidney that has been transported by drone. Apart from the mode of transport of the graft, organ procurement, preservation, transplantation, treatments and follow-up are carried out according to usual care, with no additional examination required by the study. The main outcome is the absence of delayed graft function, defined as no need for dialysis during the first week after transplantation. Cold ischemia time, transport time, temperature and vibrations during transport, transport costs, events preventing, delaying or interrupting drone missions, and adverse events up to 30 days after transplantation are also recorded. Participants are followed for 12 months after transplantation as part of routine care. Study hypothesis: transport of kidney grafts by autonomous drone between two hospitals is safe, does not impair early graft function and is operationally feasible in real conditions, thereby supporting the design of a larger multicentre study.

A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function

The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.

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).

Twice vs Thrice Weekly Hemodialysis: Clinical Outcomes and Quality of Life

This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals.

Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients

This cross-sectional study aims to determine the prevalence of secondary hyperparathyroidism among end-stage renal disease patients on regular hemodialysis and to evaluate its relationship with dialysis adequacy at Assiut University Hospitals.

AVF Awareness Among Advanced CKD Patients

This cross-sectional study aims to assess awareness regarding arteriovenous fistula creation among patients with advanced chronic kidney disease, including pre-dialysis patients and those receiving maintenance hemodialysis, at Assiut University Hospital.

Predictors of Rapid CKD Progression

This prospective observational cohort study aims to identify independent predictors of rapid chronic kidney disease (CKD) progression and determine its incidence among predialysis CKD patients. A total of 190 adult patients will be enrolled from the nephrology outpatient clinic and inpatient ward at Assiut University Hospitals and followed for 24 months. Rapid progression is defined as a sustained decline in eGFR \> 5 mL/min/1.73 m² per year according to KDIGO 2024 criteria. Clinical and laboratory parameters will be assessed at baseline and during follow-up to identify predictive factors

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

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.

Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients

People on hemodialysis need their arteriovenous fistula (a blood vessel access point) punctured with a needle three times a week, which can cause pain and worry. This study compares three ways of managing that pain: (1) usual care, (2) applying an ice pack to a specific point on the hand before the needle is inserted (cryotherapy), and (3) applying a numbing gel (lidocaine/prilocaine) to the skin before the needle is inserted. Adult hemodialysis patients with a working fistula were randomly assigned to one of these three groups. Over three dialysis sessions, researchers measured each patient's pain, anxiety, and other symptoms right before, right after, during, and after dialysis, as well as their quality of life and a physical stress marker (heart rate variability). The goal is to find out whether the ice pack method works as well as or better than usual care and the numbing gel at reducing pain and anxiety, so that a simple, low-cost, non-drug option could be offered to more patients in the future.

Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks. The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.

Characteristics,Treatment Course and Prognosis of Patients Older Than 75 Yrs Old Reaching End Stage Renal Disease (PSPA)

Elderly (i.e.\>75 yrs) represent about 40% of incident dialysis patients in the French REIN Registry and are growing population in high income countries. Those elderly patients with CKD have a high risk of dying within the first months of dialysis start or could have a good long-term prognosis suggesting kidney transplantation access. Elderly patients with CKD also have a higher risk of dying than reaching ESRD. Therefore, outcomes of elderly patients with advanced CKD need to be better described and understood to be able to give accurate information to the patients and their relatives and help decision making concerning the treatment strategy including several options (i.e preemptive kidney transplantation, in center or home dialysis and conservative care). In France we have information about patients who started dialysis with French dialysis registry (REIN) but not about elderly patient treated with conservative care. Then we don't have information about description of the therapeutic project in this population and their evolution in a prospective cohort design. Finally we need to identify patients with high risk of early mortality to help shared decision making for better care organisation. The project of the study is the development of a French multicenter prospective cohort including elderly patients more than 75 years old reaching ESRD. Objectives are as follow: Description of the characteristics of the population such as, clinical and social conditions, medicine treatment, therapeutic project declared by nephrologist and laboratory value at inclusion. Description of the evolution of therapeuic project, kidney function and the outcomes defined as death or dialysis or kidney transplantation. Development of a mortality prognosis tools to help decision making in this population.

Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol

This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems. The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology. The results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use. In short, this work aims to help patients reach the day of their surgery in the best possible condition.

Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)

The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant. Patients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely. This study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch. The investigators hypothesize that this procedure will eliminate the "immunological memory" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a "naive" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.

Empagliflozin in ESKD - A Feasibility Study

The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.

HOLT-ED: Holter-monitoring in End-stage Renal Disease

The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Effects of Royal Jelly Supplementation in Chronic Kidney Disease

The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).

International (Pediatric) Peritoneal Biobank

Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent. An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime. 3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.

A Communication Tool to Assist Older Adults Facing Dialysis Choices

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on receipt of palliative care and intensity of treatment at the end of life, quality of life, and quality of communication for older patients with end-stage renal disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and is now being testing to see if the intervention will work in a different setting. The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD) and are receiving care from a nephrologist enrolled in the study. Randomly assigned nephrologists within each site will receive the intervention (training to use the BC/WC tool) or to be in the waitlist control, meaning that they will not be offered BC/WC training until the end of the study, when all participants have been enrolled. Participants will be on follow up with surveys and chart review for up to two years after study enrollment. Caregivers will also be invited to participate and complete surveys.