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Showing 1-20 of 125 trials
NCT07446296
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. The main questions it aims to answer are: * Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list? * Do participants follow the exercise program and wear a physical activity tracker as asked? * Is the program safe and well tolerated? Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function: * Usual pre-transplant care with a physical activity tracker * Usual pre-transplant care plus an online exercise program Participants will: * Wear a wrist activity tracker to measure daily physical activity * Complete a one-week baseline period before being assigned to a study group * Be randomly assigned (like flipping a coin) to one of two groups * If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback * Answer questionnaires about their health, activity, and experience in the study This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
NCT07369323
Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on dialysis are hepatitis C or hepatitis B virus positive, and the use of other effective analgesics, such as acetaminophen, is limited.The use of regional analgesia methods for postoperative analgesia can also be a useful option for more adequate control in these patients. Currently, methods of fascial trunk nerve blocks (including rectus sheath block, different types of transversus abdominis plane block, and erector spinae plane \[ESP\] block) have been shown to be effective components of multimodal anesthesia in various fields of surgery.In this study, investigators evaluated the effectiveness of ESP block in the postoperative period after kidney transplant.The aim of this prospective, randomized controlled trial is to evaluate the effects of erector spinae plane block on postoperative analgesia quality, opioid consumption, and side effect profile in kidney transplant patients.The study included a total of 40 patients aged 18-65 years with ASA physical status II-III who were scheduled for elective kidney transplantation. All patients received standard general anesthesia. Anesthesia induction was achieved with propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg). Anesthesia maintenance was provided with 6% desflurane and a 50% oxygen-air mixture.ESPB Group: USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml) * Control Group: no block applied * All patients received standard postoperative analgesia protocol. Intravenous paracetamol (1 g/8 hours) was given. Intravenous tramadol (100 mg) was administered as rescue analgesic when VAS ≥ 4.
NCT07257614
Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke/transient ischemic attack and major bleeding compared to standard care. Instruments: The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison. Main Outcome Measures: The primary endpoint is the composite of stroke/transient ischemic attack/systemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of \<0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.
NCT06056102
This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.
NCT06343727
The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: * To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. * To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. * To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.
NCT06972069
This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.
NCT05656040
This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) \[Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)\]. The primary hypothesis for Part 1 was that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants would be at least 11300 nM\*hr.
NCT06866236
Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study the investigators are using a novel drug to target improved function of the kidneys.
NCT04277377
Magnetic nanoparticles, coated with human leukocyte antigens (HLA) to capture anti-HLA antibodies with donor specificity (donor-specific antibodies, DSA), will be tested ex-vivo.
NCT07113574
Peritoneal dialysis-associated peritonitis (PDAP) remains one of the most serious complications in patients undergoing peritoneal dialysis (PD), contributing significantly to hospitalization, technique failure, and mortality. Intraperitoneal (IP) antibiotic administration is the standard of care in PDAP, as it provides high local drug concentrations at the site of infection. However, dosing recommendations are largely based on pharmacokinetic (PK) studies in continuous ambulatory peritoneal dialysis (CAPD) patients. Automated peritoneal dialysis (APD), now widely used, differs significantly from CAPD in terms of dialysate volumes, frequency of exchanges, and peritoneal clearance. As a result, extrapolation of CAPD-based dosing regimens may lead to antibiotic underdosing in APD patients. This prospective, open-label, single-center descriptive PK study investigates the plasma and dialysate concentration-time profiles of meropenem and aztreonam after IP administration into the short-dwell cycler exchanges during nighttime APD. The rationale is that administration into the early short dwells may ensure adequate antibiotic levels both during active cycling (when frequent exchanges may clear the drug rapidly) and during the subsequent long daytime dwell through back-diffusion from systemic circulation. Twelve stable APD patients without peritonitis will be enrolled (6 per drug group). Inclusion requires patients to be on a stable APD regimen for at least one month using glucose-based dialysate for short nighttime dwells and Icodextrin for the daytime dwell. Patients with current infections, recent peritonitis, or significant comorbid conditions are excluded. On the study day, each participant will receive either: Meropenem: 0.75 g added to a 5L glucose-based peritoneal dialysis fluid (PDF) bag, or Aztreonam: 2 g prepared similarly. The antibiotic-containing 5L PDF bag is used as the first bag in the APD cycler session, followed by a second 5L antibiotic-free PDF bag, yielding a total of five 2L nighttime exchanges. After cycler therapy, a 1.5L Icodextrin fill is instilled for the long daytime dwell. Sampling includes: Venous blood: at 0 (pre-dose), 1, 2, 4.5, 6.5, 9, 10, 12, 16, and 24 hours. Dialysate: inflow/outflow from each cycle and at defined intervals during the Icodextrin dwell (up to 24 hours). Urine: 5 mL from a 24-hour collection in patients with residual renal function. Drug concentrations in plasma, dialysate, and urine will be quantified using validated high-performance liquid chromatography (HPLC) techniques. Primary PK endpoints include area under the curve (AUC), maximum plasma concentration (Cmax), time to reach Cmax (Tmax), and half-life (t½) in each compartment. Secondary endpoints include ratios of AUC and Cmax across compartments, time above the minimal inhibitory concentration (T\>MIC), and AUC0-24/MIC. This study does not include formal hypothesis testing but aims to generate descriptive PK data to inform optimized dosing of meropenem and aztreonam for APD patients. Currently, there is a lack of pharmacokinetic data guiding IP antibiotic dosing specifically in APD. The study's findings may support more accurate and effective antibiotic administration protocols for PDAP and potentially for the treatment of other systemic infections (e.g., pneumonia) in this population. The anticipated benefit is improved antimicrobial efficacy through better PK/PD target attainment while avoiding the need for intravenous therapy. The risk to participants is minimal, consisting primarily of standard procedures (blood draws, single-dose IP drug administration). Ethical approval has been obtained, and all participants will provide written informed consent. The study complies with Good Clinical Practice (GCP) and relevant regulatory and ethical standards, including the Declaration of Helsinki.
NCT06314503
The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).
NCT06288451
The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care).
NCT06659835
The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are: What amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy? Amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.
NCT06857188
The assessment of AI -based prediction models in detecting AKI early in critically ill patients. Specifically, the aim is to evaluate the model's ability to predict the onset of AKI before it clinically manifests allowing for early interventions
NCT03546205
The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.
NCT06438445
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).
NCT03640026
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation. In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality. Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation. Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function. In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment. No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows: HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0 These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.
NCT05418816
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).
NCT03380962
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.
NCT03476460
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol. Patients \>65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate \<30 ml/min, serum potassium \<3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study. Contrast nephropathy will be defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25% from baseline, in the first 48 hours after contrast administration.