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Kidney Transplantation clinical trials

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NCT ID: NCT02421497 Recruiting - Clinical trials for Chronic Kidney Diseases

MRI Technical Development and Applications in Kidney Disease

Start date: March 30, 2023
Phase:
Study type: Observational

Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to: 1. develop, customize, and optimize anatomic and functional MRI methods, 2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and 3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction. In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.

NCT ID: NCT02351427 Recruiting - Clinical trials for Kidney Transplantation

Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation

Start date: February 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.

NCT ID: NCT02208791 Recruiting - Clinical trials for Kidney Transplantation

Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

Start date: July 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.

NCT ID: NCT02154815 Recruiting - Clinical trials for Kidney Transplantation

Pre-emptive Kidney Transplantation Quality of Life

PreKiTQoL
Start date: September 2014
Phase: N/A
Study type: Observational

The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

NCT ID: NCT02104024 Recruiting - Clinical trials for Kidney Transplantation

CEUS in Kidney and Pancreas Transplantation

Start date: October 2013
Phase: N/A
Study type: Observational

This study is to investigate whether it is possible to use a special type of ultrasound scan (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome, involves nuclear medicine and takes 45- 60 minutes to complete. We do not routinely image the blood supply to the pancreas post-surgery, despite the most common complication post pancreas transplantation being vascular in origin. In an emergency a CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner and injection of contrast which is harmful to the kidneys. CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can be carried out at the bed-side, provides instant results and is cheap and safe enough to do on a routine basis for all kidney and pancreas transplant recipients. Although the uses of CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has been compared to other modes of imaging and has been found to be comparable/ beneficial. However, it has never been compared to Transcan. We will therefore perform CEUS on our kidney transplant recipients and compare the results to Transcan. We will also assess whether CEUS is able to visualise the blood supply to the kidney and pancreas and quantify the perfusion to the pancreas.

NCT ID: NCT01837043 Recruiting - Kidney Transplant Clinical Trials

Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of conversion from a calcineurin inhibitor (tacrolimus or cyclosporine) immunosuppression therapy to Nulojix® (belatacept) immunosuppression therapy in patients with delayed (DGF) or slow graft function (SGF) following kidney transplantation. Patients at risk for SGF or DGF will be consented at the time of kidney transplantation. On post-op Day 5 the patient will be assessed, if they have developed SGF or DGF they will be randomized to convert to Belatacept or continue on their CNI regimen. Up to 20 subjects who do not develop DGF will be followed as control subjects. Seventy randomized subjects will be followed for a total of 14 months with a renal biopsy at Month 12 post transplant. Research Hypotheses: Primary Hypotheses: - Kidneys with slow or delayed graft function are more susceptible to acute and long-term CNI toxicity - Kidneys converted from calcineurin inhibitor based therapy to belatacept will achieve a more rapid recovery from post-ischemic acute tubular necrosis (ATN) and will have improved 1 year calculated GFR. Key Secondary Hypotheses: - Renal Histology: Belatacept converted patients will have a lower chronic allograft damage index (CADI) score and lower interstitial fibrosis and tubular atrophy (IF/TA) score as calculated by Banff criteria at 1 year post- transplant - Biomarker Analysis: Biomarker analysis (clusterin) measured in serial urine collections can 1) directly assess CNI induced kidney injury and 2) improve the prediction of patients that benefit in early belatacept conversion.

NCT ID: NCT01834768 Recruiting - Clinical trials for Kidney Transplantation

EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety

EpleCsAT
Start date: February 2013
Phase: Phase 2
Study type: Interventional

Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A) are widely used. Their renal toxicity could be divided between an acute toxicity (toxic arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy, interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have shown the implication of the mineralocorticoid receptor (MR) activation in those toxic phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the renal function and kidney histological damages. Several antagonists are available in France but none is indicated in kidney transplantation. Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and to have less adverse anti-androgenic effects than others molecules. Its principal adverse events are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists, especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced by calcineurin-inhibitors. Classically, eplerenone is contra-indicated in patients presenting with an impaired renal function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a warning is especially notified for the association with cyclosporine A due to the fact that no study have been done in this context. The investigators study first the safety of the use of eplerenone in association with cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will study its efficiency in a large randomized controlled trial.

NCT ID: NCT01699360 Recruiting - Clinical trials for Kidney Transplantation

The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the potential of endogenous cortisol and cortisone metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal transplant recipients. If the blood concentrations of immunosuppressants can be predicted successfully, this new probe may take place of current drug monitoring post transplantation.

NCT ID: NCT01615341 Recruiting - Clinical trials for Kidney Transplantation

Study of Subclinical Viral Infection

Start date: October 2011
Phase: N/A
Study type: Observational

Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. The pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. The hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. The young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. The studies outlined will determine the temporal relationship betWeween subclinical viremia, renal allograft infection and allograft injury. This will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. In addition, the role of virus specific T cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. These data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. Importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. Thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.

NCT ID: NCT01608412 Recruiting - Clinical trials for Kidney Transplant Recipients

A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The study hypotheses to be tested in this study are: - Conversion to everolimus at 3 months post-transplantation is safe and effective; - Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients; - Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.