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Kidney Transplantation clinical trials

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NCT ID: NCT01158742 Completed - Clinical trials for Kidney Transplantation

Live Kidney Donor Study -Renal Function Study

Start date: September 2009
Phase: N/A
Study type: Observational

Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. In particular, data concerning the extent of renal function decline after donation are inadequate. This study will measure glomerular filtration rate (GFR) in previous living donors and aims to more accurately describe renal function after kidney donation.

NCT ID: NCT01157884 Completed - Clinical trials for Kidney Transplantation

Change of Body Composition After Kidney Transplantation in Korea

Start date: September 2009
Phase: N/A
Study type: Observational

The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients. The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA). In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).

NCT ID: NCT01157234 Completed - Hypertension Clinical Trials

Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses: 1. Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients. 2. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients

NCT ID: NCT01143532 Completed - Clinical trials for Kidney Transplantation

Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

Start date: August 12, 2010
Phase:
Study type: Observational

Background: - Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants. Objectives: - To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients. Eligibility: - Participants in kidney transplant where both donor and recipient were of black African descent. - Eligible transplants include both living donor and deceased donor. Design: - The study will involve one visit of up to 8 hours. - All participants will provide a detailed personal and family medical history. - All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing. - Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.

NCT ID: NCT01140035 Completed - Kidney Transplant Clinical Trials

Intensive Insulin Therapy in Deceased Donors

Start date: January 2009
Phase: N/A
Study type: Interventional

Every year in the US, there is a shortage of many thousands of kidneys needed for transplant. Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow graft function (DGF and SGF, respectively), which lowers quality of life for patients and their families and requires significant additional medical care. These needs result in significant but preventable human suffering and health care spending. To address these needs, the investigators' project will test the use of intensive insulin therapy (IIT) in donors after neurological determination of death (DNDDs) as an intervention that will decrease acute kidney injury and improve renal function at the time of organ recovery. This should translate into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group. The investigators also expect to find a trend toward an increase in the number of organs available for transplant due to better organ protection in the DNDD. Taken together, these data can provide the requisite justification for a larger study that can be powered to evaluate the effect of IIT on increasing the number of kidneys available for transplantation. There is evidence that brain death often leads to hyperglycemia that may negatively impacts the organs of DNDDs. These observations led us to conduct a retrospective study, in which the investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal renal function. Because it has been reported that intensive insulin therapy (ITT) is renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in recipients, and (3) possibly increase the number of kidney available for transplant. Methods: This is a prospective observational study to document the impact of IIT on acute kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of ITT on biochemical parameters in blood samples that predict kidney health and function in DNDDs. All methods used in this proposal are well documented in the literature and established in the applicant's laboratory. In the investigators' second study, they will compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of number of patients showing either DGF or SGF. Additionally, there is currently no established set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients. The investigators will correlate the evaluated biochemical markers of kidney function and health in order to possibly develop more refined methods of predicting transplant success. Such a set of criteria would be useful for designing studies to systematically test additional interventions in DNDDs to further improve organ function before recovery and further increase the number of available organs. Taken together, the results of this study may lead to new therapies that significantly improve patient outcomes while significantly reducing disease associated costs. These results can also set the stage for a follow on study for increasing the number of kidneys available for transplant.

NCT ID: NCT01136395 Completed - Clinical trials for Kidney Transplantation

Impact of Rituximab (RTx) Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation

Start date: January 2010
Phase: Phase 2
Study type: Interventional

This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK virus (BKV), JC virus (JCV), cytomegalovirus (CMV), Epstein Barr virus (EBV)) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.

NCT ID: NCT01134510 Completed - Clinical trials for Kidney Transplantation

Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection

Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since pre-formed antibodies will cause severe rejection and loss of transplanted organs. Approximately 30% of the transplant list in the U.S. is considered sensitized (have detectable antibodies to HLA antigens). These anti-HLA (anti-Human Leukocyte Antigen antibodies) pose a significant barrier to transplantation that has recently been successfully addressed using desensitization therapies with IVIG, rituximab and/or plasmapheresis (PE). Despite the success of these therapies, post-transplant antibody mediated rejection (AMR) and chronic Antibody Mediated Rejection (CAMR) remain significant problems. Recent data suggests that addition of Berinert (C1 Inhibitor) to post-transplant treatment regimen may significantly reduce incidence of Antibody Mediation Rejection. Twenty highly-sensitized patients who have undergone desensitization treatment and are awaiting kidney transplant will be enrolled in the study. Once transplanted these patients will be started on the standard of care post-transplant immunosuppressive protocol. In addition patients will receive Berinert 20 units/ kg daily x 3 days, then twice weekly x 3 weeks. At the end of Berinert treatment a kidney biopsy will be performed. Subjects will be followed for 6 months to assess safety and efficacy of the study protocol.

NCT ID: NCT01126333 Completed - Kidney Transplant Clinical Trials

Long-term Follow-up of Spare the Nephron (STN) Patients

STN
Start date: June 2010
Phase:
Study type: Observational

Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors. "Spare the Nephron"(STN) is a unique study. Patients were randomized to either continue center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus within the first six months after transplantation. Approximately 305 patients were enrolled in the study. More than 230 patients finished 2 years of follow-up. There was better patient and graft survival in those converted to sirolimus. There was also a 10% improvement in the kidney function of those who were converted. In this cohort, we wish to explore the durability of this improvement.

NCT ID: NCT01120028 Completed - Clinical trials for Kidney Transplantation

Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

3C
Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.

NCT ID: NCT01109914 Completed - Clinical trials for Kidney Transplantation

Mucosal Response in Immunocompromised Host

MICH
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).