View clinical trials related to Kidney Transplantation.
Filter by:LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and no new safety concerns. - Stable kidney transplant patients can be safely converted from Adoport® twice-daily to LCP-Tacro®. - The greater bioavailability of LCP-Tacro after once-daily dosing results in similar (AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®. - LCP-Tacro provides a slow drug release and this results in flatter kinetics characterized by significantly lower peak-trough fluctuations. - CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12 for tacrolimus. - CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not correlate with an increase in the CN activity.
Kidney transplant thrombosis (loss of blood flow) is responsible for up to 35% transplant failures in children. Detection of kidney transplant thrombosis currently relies on recognition of deterioration in parameters such as urine output and blood creatinine levels, which change relatively slowly. Confirmation is then required with an ultrasound scan. There is inherent delay in the above process, during which time some or all of the transplant kidney tissue can die, which can result in failure of the transplant. Near infrared spectroscopy (NIRS) is a non-invasive technique used in continuous monitoring of oxygen levels in several organ systems including the brain, muscles, gut, liver and native kidneys. We hypothesise that NIRS can be applied to monitor kidney transplant blood flow in real time. We aim to test the use of NIRS in detecting blood flow in established kidney transplants in children, and to compare it with ultrasound, the current gold standard measurement. Existing NIRS equipment would be used within its CE marked purpose measuring oxygen levels; this mechanistic study would extrapolate measured oxygen levels to determine blood flow. Participating children attending outpatient clinic for routine transplant ultrasound scans will have NIRs monitoring for a 10 minute period. NIRs data will be compared to a validated perfusion score from ultrasound images. If this study is successful, NIRS could provide continuous monitoring of kidney transplant blood flow in the postoperative period, thus allowing immediate detection of blood flow problems. This has potential to reduce kidney transplant failures from thrombosis.
The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up were imputed as rFSGS.
Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation
The main objective of this multicentre study is to conduct the evaluation of cost-efficiency of various techniques of kidney taking with regard the quality of life of the kidney living donors. It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery pure or " hand-assisted " and cœliosurgery assisted by robot) and to determine their respective advantages in quality of life, then their medico-economic consequences in a cost-efficiency approach from the point of view of the society. The evaluation will concern the donor and the receiver followed three months after the taking. The open donor nephrectomy will be the technique of reference with which will be compared the two others.
Ciclosporin A (CsA) is an immunosuppressive drug used in organs and tissues transplantations (kidney, heart, liver, bone marrow ...) to prevent rejection, and in different autoimmune or inflammatory diseases. A therapeutic drug monitoring (TDM) is required during a CsA treatment. It is justified by a narrow therapeutic range between efficiency and nephrotoxicity, and by large intra- and interindividual pharmacokinetic variability. TDM of CsA is conventionally performed by determining residual concentration, and sometimes concentration at 2 hours after administration. TDM of CsA is currently performed by venous sampling on ethylenediaminetetraacetic acid (EDTA). Dried blood spot (DBS) sampling could be a particularly interesting alternative to conventional blood sampling. With DBS, capillary blood is obtained from a finger prick by the patient himself, and the blood drop obtained is deposited on filter paper, which can be stored at room temperature and then be sent to the laboratory by mail. This sampling method has several advantages : it requires small blood volumes, it is less invasive than conventional venous sampling, sampling can be performed by the patient himself at home few days before the consultation, and the results of the analysis can be available to the clinician on the day of consultation, allowing dose adjustment more quickly. Several studies have been published in recent years using DBS sampling method, for various drugs such as antimalarials, antiepileptics, antiretrovirals, metformin, benzodiazepines, or immunosuppressants. Only one clinical validation study of TDM of CsA using DBS method was published by Wilhelm et al. (2013) in a population of 38 patients who received allogeneic stem cell transplant recipients. The results showed excellent correlation between the concentrations determined by the two sampling methods. The investigators propose an observational study at the University Hospital of Caen for clinical validation of DBS sampling for TDM of CsA in kidney transplantation, for which there are no data published. During a nephrology consultation, for each patient, venous and finger prick blood samples are simultaneously collected. CsA assays were performed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the two sampling methods. A specific LC-MS/MS assay method applied for DBS samples was developed and validated for this study (DBS/LC-MS/MS). Correlation between the results obtained from the two sampling methods will be evaluated, on at least 100 samples. Patients have to answer a questionnaire to assess pain and comfort of DBS sampling, and feasibility of self-sampling at home by this method. The aim of this clinical validation study of DBS sampling is the establishment of the systematic TDM of CsA for renal transplant patients by DBS sampling at the University Hospital of Caen.
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers. Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Aim of this clinical study is to establish a novel technique, the so called intraoperative fluorescence angiography, for kidney graft perfusion visualization during the transplant procedure.
This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first year post-transplant.