Clinical Research Directory

Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination

The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis. Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease. Participants will: * Be enrolled at the time of influenza vaccination * Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination * Be asked to provide relevant clinical information and a blood sample at each visit

The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease

The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health. The main questions are: * Does amino acid treatment reduce the risk of death in dialysis patients? * Does it improve the health of the heart and blood vessels? * What side effects or medical problems happen when patients receive amino acids during dialysis? In this study: * Participants will be randomly assigned to receive either amino acids (Synthamin 9®) or a placebo (saline). * The infusion (250 ml) will be given twice a week during dialysis sessions for 12 months. * After 12 months of treatment, patients will be followed for another 6 months. During the study, patients will: * Have regular blood tests to measure markers of blood vessel health, inflammation, and protein carbamylation. * Undergo heart and vessel tests, including echocardiography, CT scans, and pulse wave velocity measurements. * Complete quality-of-life questionnaires about symptoms and daily living. By comparing the amino acid group with the placebo group, researchers will see whether amino acid therapy can make dialysis patients live longer and have healthier hearts and blood vessels.

Impact of Dialysis on Sexuality.

Sexuality is an essential dimension of quality of life and is frequently impaired in patients with end-stage chronic kidney disease undergoing hemodialysis. Sexual dysfunctions-including erectile dysfunction, reduced sexual desire, and difficulties with arousal or orgasm-are highly prevalent in this population. These disorders have multifactorial origins, involving hormonal disturbances, comorbidities, treatment-related side effects, chronic fatigue, and the psychological and relational impact of long-term illness. Despite their frequency, sexual health issues are rarely addressed in routine dialysis care. This is largely due to time constraints during consultations, insufficient training of healthcare professionals, and persistent social and cultural taboos. In addition, the existing scientific literature remains limited, often outdated, and predominantly focused on male patients. Data concerning women, sexual diversity, body image, and couple-related aspects are scarce. Standard kidney disease-specific quality-of-life instruments, such as the KDQOL questionnaire, provide only a minimal assessment of sexuality, with a single item related to sexual desire. The aim of this study is to provide a contemporary and comprehensive assessment of the impact of dialysis on sexual quality of life. By documenting sexual function and sexual complaints in patients undergoing dialysis, this study seeks to improve understanding of patients' experiences and to facilitate communication between patients and healthcare professionals. Ultimately, the findings are intended to support better integration of sexual health into routine nephrology care and to contribute to improved clinical practices in the field of sexual health. This study is designed as a cross-sectional survey conducted among patients undergoing dialysis at the Groupe Hospitalier Privé Ambroise Paré-Hartmann in the Paris area. Eligible patients are informed about the study during a dialysis session by a healthcare professional (dialysis nurse, nephrologist, or physiotherapist specialized in sexology). Participants complete a self-administered questionnaire during their dialysis session, including the Male Sexual Health Questionnaire (MSHQ) for men and the Female Sexual Function Index (FSFI) for women. Additional questions addressing medical history and body image perception are included. The estimated completion time for the questionnaire is approximately 20 minutes.

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).

Smart and Fit for Kidney Transplantation

This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.

Integrating BIA and eGFR for Nutritional Status in Hemodialysis Patients

This study looks at how measurements of body composition from Bioelectrical Impedance Analysis (BIA) and estimates of kidney function (eGFR) can be applied together to better assess the health of people on hemodialysis. Many dialysis patients struggle with malnutrition, muscle loss, and fluid imbalances, but current assessment methods rely on unsophisticated tests and observations. By combining BIA and eGFR, this study aims to provide a more accurate and non-invasive way to monitor nutrition and overall health, which could lead to better treatment decisions and improved patient outcomes.

Fluid Intake After Hemodialysis

Interdialytic weight gain determines how much fluid (ultrafiltration) has to be removed during each hemodialysis session. High ultrafiltration volumes stress the organism and lead to a higher risk of death. Thirst is the main driving factor of interdialytic weight gain, and thirst is mainly driven by salt intake, molecules that increase blood tonicity (such as sugar in diabetics) and fluid loss (such as in dehydration and blood loss). It has been speculated that fluid loss during hemodialysis could increase the sense of thirst immediately following dialysis, but this statement requires further evidence.

Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Therefore, while determining the psychosocial aspects of the disease gains importance, it is reported that determining and evaluating the biopsychosocial characteristics may facilitate the disease management of individuals. Considering that CKD is associated with various comorbidities, psychosocial features, and symptom burden, it is interpreted that patient-reported outcome measures may support the complex management of these individuals. Routine collection and use of patient-reported outcome measures may provide valuable data for understanding the disease from both individual and community perspectives, with the potential to improve the quality of care and outcomes. The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed for patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically assesses many biopsychosocial characteristics of the person, such as pain, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that assess these symptoms holistically in chronic kidney disease. BETY-BQ can be envisaged as an assessment tool for interdisciplinary healthcare team members who want to evaluate the CKD population, including individuals on dialysis and kidney transplant recipients. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic diseases, it aimed to examine its validation in this disease group. In this study, which investigators planned to contribute to this field, investigators aimed to investigate the validity, reliability, and sensitivity of BETY-BQ in individuals diagnosed with chronic kidney disease on dialysis and kidney transplantation.

Lumasiran in Hyperoxalaemic Patients on Haemodialysis

This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis. The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study. At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.

Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.

Patients with end-stage renal disease undergoing hemodialysis (HD) are burdened with extremely high mortality rates (15% per year) and during the early stage (≤120days) the mortality rate is even higher (27% per year). Cardiovascular complications and bloodstream infections (BSIs) account for the vast majority of deaths in HD patients. In Denmark, BSIs occur in 14% of HD patients per year and is most frequently caused by Staphylococcus aureus (44%). The most frequent infectious complication is endocarditis that has fatal outcomes in ≈50% of the cases. Overall, 10% of HD patients die within 30 days after a positive blood culture for S. aureus. This project aims to answer key questions regarding HD patients' decreased ability to fight S. aureus BSIs and in particular the potential exacerbating effect of HD. We hypothesize that HD patients' blood is significantly compromised by the process of HD, to an extend that lowers immunoactivity against S. aureus. Moreover, we hypothesize, that contact activation promotes the coagulability of blood thus promoting biofilm formation by S. aureus which increases the overall risk of BSI. We will test these hypotheses by collecting blood and analyzing the inflammation and coagulation status in plasma samples from participants before and after HD. We will compare the level of the inflammatory markers in plasma from participants undergoing HD (n=180) to the level in plasma samples from three control groups: healthy volunteers (n=120), participants with renal disease not in dialysis (n=60) and participants undergoing peritoneal dialysis (n=40).