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Kidney Transplantation clinical trials

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NCT ID: NCT02908139 Recruiting - Clinical trials for Kidney Transplantation

Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Start date: September 2016
Phase: N/A
Study type: Observational

Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation

NCT ID: NCT02907554 Recruiting - Clinical trials for Kidney Transplantation

Cyclosporine A Pretreatment and Kidney Graft Function

Cys-A-Rein
Start date: December 19, 2017
Phase: Phase 4
Study type: Interventional

Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

NCT ID: NCT02900040 Recruiting - Clinical trials for Kidney Transplantation

Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation

DIVAT
Start date: January 1994
Phase: N/A
Study type: Observational [Patient Registry]

The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in french, and in English "Computerized and VAlidated Data in Transplantation" ) cohort was Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes University Hospital in France. The primary objective of this multicenter computerized database was to enable prospective clinical and epidemiological research studies concerning kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes, therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort allows the monitoring of medical records of all patient-specific and allograft-specific data, including bio-banking since 2005. Data are collected from the date of transplantation until the graft failure, at each scheduled outpatient visit or hospital admission motivating by a new clinical, therapeutical or biological expression. The DIVAT cohort contains information on more than 11000 transplant recipients between 1994 and today, issued from 8 French university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18% of all patients underwent retransplantation and 11% of all kidney transplants originated from living donors. The DIVAT network heavily works to ensure a high-quality data collection with the aim of exploring adequately the complex post-transplantation process. The Divat network encourage collaborations and enables interested researchers to submit a research project by completing a request form available on the DIVAT website (http://www.divat.fr/en) describing the context, objectives and design of the study

NCT ID: NCT02878616 Completed - Clinical trials for Kidney Transplantation

Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316

Start date: August 26, 2016
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT02839941 Recruiting - Clinical trials for Kidney Transplantation

Iguratimod in Kidney Transplant Recipients

Start date: August 2016
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the effect of iguratimod concomitant with conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly mismatched Kidney Transplant recipients.

NCT ID: NCT02832661 Recruiting - Clinical trials for Kidney Transplantation

BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients

BECS
Start date: March 2015
Phase: N/A
Study type: Observational

Biomargin is a European research program aimed at evaluating the diagnostic performance of biomarkers with respect to renal graft injuries, as well as their prognostic performance with respect to 3-year and 5-year graft outcomes. Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of individual kidney graft lesions will be determined systematically in urine and blood samples collected in patients from the time of transplantation onwards, as well as in the graft tissue when biopsies are required for medical causes or performed systematically in the investigation centres. Their diagnostic and prognostic performance will be checked against histological reading of the biopsies and evolution of the graft function over time.

NCT ID: NCT02830568 Completed - Clinical trials for Kidney Transplantation

Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors.

DOVIREIN
Start date: June 2010
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02830191 Completed - Clinical trials for Kidney Transplantation

Therapeutic Drug Monitoring (TDM) of Cyclosporine in Kidney Transplant Patients by Dried Blood Spot Assay. Interest and Feasibility.

CICLOSPOT
Start date: November 2014
Phase:
Study type: Observational

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.

NCT ID: NCT02827695 Completed - Hypertension Clinical Trials

Smart Phone Medication Adherence Saves Kidneys--SMASK

Start date: May 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02808065 Recruiting - Clinical trials for Kidney Transplantation

Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Start date: May 2016
Phase: N/A
Study type: Observational

Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.