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Showing 1-14 of 14 trials
NCT02849899
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation. There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group. No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on β cells and anti-inflammatory effect. The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.
NCT00167661
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
NCT03263052
This study will investigate whether converting patients from FDA approved immediate-release tacrolimus to FDA approved extended release tacrolimus (Envarsus) reduces neurological side-effects, improves quality of life, and enhances adherence. A select group of elderly (\> 60 years of age) patients, who are especially sensitive to tacrolimus-related adverse (AEs) effects, will be provided the opportunity to convert to Envarsus with this study.
NCT02751099
Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated with life-threatening complications, including fractures and cardiovascular (CV) events. Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity. Still, bone disease persists after transplantation. The investigators hypothesize that bone-derived hormones can induce CV events in kidney transplanted patients. Therefore, early evaluation of the bone health is recommended, and prevention of its complications is required. Bone biopsy, an invasive and expensive method, is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for bone disease are necessary. Classical biochemical markers of bone formation and resorption have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor 23 (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting CKD-associated bone and CV disease after transplantation. This study assesses the phenotype of bone disease after transplantation (given by bone histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate its performance predicting CKD-associated bone and CV disease.
NCT02581436
This study evaluates the addition of "Kidney Solid Organ Rejection Test" (kSORT), in the clinical follow-up of renal transplant recipients, compared to clinical standard surveillance in the first two years after kidney transplantation. The design of the study is a partially blinded, randomized control trial of patients with living and deceased donor. The recruitment will be in a third level attention hospital in Mexico city (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate and grade of acute rejection, histologic chronic index of the one year protocol biopsy and glomerular filtration rate.
NCT02515643
Endothelial dysfunction one-year after transplantation mainly depends on transplant-associated factors and only marginally on reduced renal function. OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial dysfunction in two cohorts of patients, living kidney donors and their transplant recipients. Secondary objectives To evaluate in both cohorts of patients before and after nephrectomy/transplantation the evolution of the following parameters: 1. Renal function (iohexolGFR, proteinuria/microalbuminuria). 2. Blood pressure (24 h ambulatory blood pressure measurement) 3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial index, pulse wave velocity). DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts: living kidney donors and their transplant recipients.
NCT02857907
The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune senescence. Markers of immune senescence expression is assessed in a prospective cohort of renal transplant recipients the day of transplantation and one year after renal transplantation.
NCT02683291
There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.
NCT02490020
Although donation after cardiac death(DCD) is the major source of renal transplantation in China, high incidence rate of rejection and delayed graft function(DGF) is existing due to the prolonged ischemia time. According to the previous single center study, mesenchymal stem cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there was no perspective multicenter controlled study to confirm it. This perspective multicenter controlled study will focus on clarifying the key role of MSC applied via renal arterial or peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The investigators have established GMP workshop and solid research foundation of transplant rejection. This study will provide a new reasonable way for immune induction of renal transplantation by DCD.
NCT01561404
This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.
NCT01646099
This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.
NCT01195194
The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.
NCT01741064
The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.
NCT01524601
Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.