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Kidney Transplantation clinical trials

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NCT ID: NCT02078193 Completed - Clinical trials for Kidney Transplantation

Efficacy of Belatacept in Reducing DSA

Start date: November 2013
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).

NCT ID: NCT02057484 Completed - Kidney Transplant Clinical Trials

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

ADDRESS
Start date: March 3, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

NCT ID: NCT02034747 Completed - Kidney Transplant Clinical Trials

A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

COSMOS
Start date: November 21, 2013
Phase: Phase 4
Study type: Interventional

This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

NCT ID: NCT02005562 Completed - Clinical trials for Kidney Transplantation

OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Start date: May 2006
Phase: Phase 3
Study type: Interventional

This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.

NCT ID: NCT02000869 Completed - Clinical trials for Kidney Transplantation

Impact of Arterial Stiffness and Central Aortic Blood Pressure on Kidney Transplant Outcomes

Start date: January 2014
Phase:
Study type: Observational

People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this increased risk is complex but there is strong evidence that changes in arterial stiffness play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is significantly associated with the future risk of clinical events. In addition, aPWV is an independent and powerful predictor of all-cause and cardiovascular mortality in patients on dialysis. Reduction of aPWV, mainly by use of an angiotensin converting enzyme (ACE)-inhibitor results in an improved survival in dialysis patients. These findings suggest that arterial stiffness is not merely a marker of arterial damage but a potentially reversible factor contributing to mortality in dialysis patients. There is strong evidence that arterial stiffness increases as glomerular filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a number of studies as a significant risk factor for CKD progression. In addition to arterial stiffness, elevated central aortic blood pressure and central pulse pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood pressure is more strongly related than standard BP measured at the brachial arteries (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery hypertrophy as well as to future cardiovascular events. Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although, successful kidney transplant has been shown to improve arterial stiffness post-transplant, we do not know to what extent the pre-transplant arterial stiffness and central aortic blood pressure and their improvement post-transplant impact the cardiovascular and allograft outcomes. In addition, it is unclear what transplant related factors are associated with improvement in arterial stiffness and central aortic blood pressure post-transplant. The goals of our study are: 1. To determine if pre-transplant central blood pressure and aortic stiffness impact post-transplant cardiovascular and kidney allograft outcomes. 2. To determine whether the changes in central blood pressure and aortic stiffness post-transplant impact cardiovascular and kidney allograft outcomes. 3. To determine the factors associated with improved central aortic blood pressure and arterial stiffness post-transplant.

NCT ID: NCT01981603 Completed - Kidney Transplant Clinical Trials

Transplant Navigator Dissemination

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel. Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.

NCT ID: NCT01914354 Completed - Kidney Transplant Clinical Trials

Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity T Cell Population

NKG2D
Start date: February 2012
Phase: N/A
Study type: Observational

This is an observational multi-center study to determine whether any single immune monitoring test or a combination of tests obtained in the first 6 months after renal transplantation correlates with acute rejection or graft loss in renal allograft recipients receiving commonly used immunosuppressive.

NCT ID: NCT01897961 Completed - Clinical trials for Kidney Transplantation

Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation

PRAM-KT
Start date: January 10, 2012
Phase: N/A
Study type: Interventional

The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique at the adult and represent approximately 2 % of the causes of terminal chronic renal insufficiency. A etiology balance assessment must be systematically realized to eliminate a secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects of idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during the stake in forgiveness of the disease. Some cases of second offense of GEM idiopathique after renal transplantation presenting antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems parallel to the increase of a proteinurie in touch with a second offense of GEM, and antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to obtain a forgiveness. A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on the native loins. The physiopathology of this affection remains unknown. Working hypothesis and objectives We shall look in which proportion the presence of antibody anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal transplantation. We anticipate that the GEM of novo of the renal transplant answers a different physiopathology, and will not be associated with the presence of antibody anti-PLA2R1. We hope to demonstrate that at the expanding patients of antibody anti-PLA2R1, the title of these antibodies is correlated in the activity of the disease and in the renal survival, and that the longitudinal follow-up of the title of these antibodies has an interest forecast and therapeutics.

NCT ID: NCT01895049 Completed - Clinical trials for Kidney Transplantation

Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria

Start date: August 2013
Phase: Phase 4
Study type: Interventional

The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.

NCT ID: NCT01889758 Completed - Clinical trials for Kidney Transplant Recipients

Pharmacokinetic Studies of Tacrolimus in Transplant Patients

PK
Start date: June 2013
Phase: Phase 4
Study type: Interventional

The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.