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Displaying 1 - 32 of 32

LT Inflammation and Immunosuppression Biomarkers

Condition: Transplant / Liver Transplant
Investigator: Yael Nobel, MD, MS
Status: Currently Recruiting
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. Tacrolimus is the primary medication used in most patients to suppress the immune system and prevent this complication after LT. The main purpose of this study is to determine if bacteria in the intestine (gut…
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INTEGRATE Cohort Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this observational research study is to identify things that contribute to outcomes in patients with alcohol-associated liver disease who are being considered for liver transplant and who have less than 6 months of sobriety. We will look at many things including images of the liver and heart, blood tests, urine tests, stool tests and liver…
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Cognitive Impairment (Problems with Thinking and Memory) in Liver Disease

Condition: Transplant / Liver Transplant
Investigator: Sloane Heller, MD
Status: Currently Recruiting
The purpose of this study is to understand how liver disease affects thinking and memory, both before and after transplant. Participants will take a cognitive test, which will be a series of tasks and questions similar to a video game, at home on their own computers, tablets, or phones. This will take approximately 45 minutes, and participants will do this…
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Characterizing Alzheimer's Disease & Related Dementias (ADRD) and risk for ADRD among liver transplant recipients with cognitive impairment

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The main purpose of this study is to deeply characterize cognitive function in liver transplant recipients, differentiate among different causes of cognitive impairment, and identify contributors to cognitive impairment. Participants will receive a comprehensive neurological exam, cognitive assessment, neuropsychological testing, MRI of the brain, and blood…
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SET-SAIL (Siplizumab in patients with AIH undergoing LT)

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis or autoimmune hepatitis undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after transplantation to prevent rejection.…
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Functional Assessment in Liver Transplantation (FrAILT) Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to learn more about the effects of functional status (also known as "frailty") using a physical test in patients with liver disease on their health outcomes. We are enrolling patients prior to liver transplantation, and will continue to assess their functional status post transplant. If you have any questions regarding…
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Liver Transplant from Donors with HIV for Recipients with HIV: Long Term Follow-up Study (HOPE)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Currently Recruiting
The primary objective is to evaluate long-term outcomes in transplant recipients with HIV who receive livers from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
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Organ Care System (OCS) Liver Perfusion (OLP-II) Registry

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Currently Recruiting
The purpose of this sponsor-initiated multi-center registry is to collect additional data on the performance of the FDA Approved OCS Liver System and post-transplant clinical outcomes for patients who are transplanted with an OCS Liver perfused donor liver in the real-world setting. If you have any questions regarding this study, please contact the…
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The NEPhrotic Syndrome STUdy NEtwork (Neptune)

Condition: Kidney Disease
Investigator: Gerald Appel, MD
Status: Closed
We are particularly interested in the diseases that cause nephrotic syndrome called Focal and Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), and Membranous Nephropathy (MN). By collecting health information and laboratory samples, our goal is to learn more about diseases and find better ways to prevent and treat people with diseases.…
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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A Study of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients (Liver Transplant)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Closed
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related…
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The BoneGN study

Condition: Kidney Disease
Investigator: Thomas Nickolas, MD, MS
Status: Closed
The CureGN Bone Study is a prospective study that is assessing the effects of 4-types of kidney disease on the skeleton. In order for us to determine the true effect of kidney disease on bone, we need to determine what healthy bone looks for patients who have the same age, race, sex, and body mass index as the patients with kidney disease. We are looking…
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A study for subjects with liver cancer using a drug to prevent recurrence of liver cancer following liver transplantation

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to determine if Nexavar (sorafenib), the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing the recurrence of liver cancer in high risk subjects…
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A study for liver transplant patients with Chronic HCV using study drug Harvoni

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (HCV) in peri-operative liver transplant patients. Harvoni (LDV/…
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HOPE in Action: Trial of HIV+ Deceased Donor Kidney Transplants for HIV+ Recipients

Condition: Kidney Disease
Investigator: Marcus Pereira, MD, MPH
Status: Closed
This research is being done to learn whether organ transplantation from HIV-positive deceased donors is as safe and effective in HIV-positive recipients as transplants from HIV-negative deceased donors. People with end-stage organ disease and HIV infection, and who qualify for organ transplantation, may join this study.
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A study of liver transplant recipients to evaluate renal function, effectiveness and safety of a study drug, everolimus

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or…
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A study for patients with Treatment Resistant Nephrotic Syndrome using study drug Abatacept

Condition: Kidney Disease
Investigator: Gerald Appel, MD
Status: Closed
A sign of your kidney disease is the presence of too much protein in your urine. The purpose of this study is to evaluate if the investigational study drug abatacept can decrease the amount of protein in your urine and improve your kidney disease beyond the treatment you have received or are already receiving. Abatacept is being used in an investigational…
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A study for kidney transplant subjects using study drug eculizumab to prevent delayed graft function

Condition: Transplant / Liver Transplant
Investigator: Lloyd Ratner, MD, MPH, FACS
Status: Closed
The purpose of this study is to determine if eculizumab is safe and could be used to prevent Delayed Graft Function (DGF) following kidney transplantation. DGF is an early complication of kidney transplantation. This condition occurs when the transplanted kidney does not recover instantly after transplantation and can take days to weeks before recovering…
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Study of MK-8228 (Letermovir) vs. Valganciclovir for Prevention of CMV Disease in Adult Kidney Transplant Recipients

Condition: Kidney Disease
Investigator: Marcus Pereira, MD, MPH
Status: Closed
The MK-8228-002 Study is studying the safety and effectiveness of an investigational medication for preventing cytomegalovirus (CMV) disease in adults with kidney transplants. The MK-8228-002 Study is evaluating an investigational medication (known as MK-8228) versus valganciclovir (VGCV). VGCV is an antiviral medication and is the current standard of care…
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A study for patients with IgA nephropathy using doses of Acthar Gel (ACTH)

Condition: Kidney Disease
Investigator: Pietro Canetta, MD
Status: Closed
The purpose of this study is to assess the most adequate dose of Acthar Gel (ACTH) in patients withIgA nephropathy. Acthar Gel (ACTH) has been approved by the Food and Drug Administration(FDA) for routine clinical use in the treatment of patients with proteinuria and patients withidiopathic nephrotic syndrome such as IgAN.
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Study for liver transplant recipients using drug (IgG) to prevent Hepatitis C virus (HCV) recurrence

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your…
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A study for patients with Focal Segmental Glomerulosclerosis (FSGS) using study drug Sparsentan

Condition: Kidney Disease
Investigator: Jai Radhakrishnan, MD
Status: Closed
The purpose of this study is to evaluate the safety and effectiveness of an investigational medication in patients with focal segmental glomerulosclerosis (FSGS). The goal is to learn whether the investigational medication may change the amount of protein in the urine and decrease proteinuria.
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Study for adult liver transplant recipients with chronic Hepatitis C infection using study drug (ABT-450/r/ABT-267)

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to see if study drugs ABT-450/r/ABT-267, and ABT-333 taken with RBV are safe and able to reduce the amount of Hepatitis C Virus (HCV) in subjects' blood over a 24-week treatment period. These drugs are intended to prevent the HCV from multiplying in the human body. Subjects who participate in this study will be expected to…
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Bone quality and mechanics in Chronic Kidney Disease

Condition: Kidney Disease
Investigator: Thomas Nickolas, MD, MS
Status: Closed
Kidney disease patients have a variety of severe bone disorders that result in rapid bone loss and fractures. We are doing this research study to determine relationships between bone quality determined from bone imaging and bone biopsy and by non-invasive measures from blood and skin. We are trying to identify non-invasive markers of bone quality in kidney…
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A study for patients with autosomal dominant polycystic kidney disease (ADPKD) using study drug Tolvaptan

Condition: Kidney Disease
Investigator: Jai Radhakrishnan, MD
Status: Closed
This study is for patients with autosomal dominant polycystic kidney disease (ADPKD). The purpose of this study is to test the effectiveness of a study drug called tolvaptan. Tolvaptan continues to be studied in this trial as a possible treatment for ADPKD. ADPKD is a disease that causes kidney cysts (cyst are like fluid-filled balloons), worsening kidney…
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Study of Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to determine if the administration of non-absorbable antibiotics (rifaximin) for the first three months after liver transplant period will reduce the amount of fibrosis (scarring of the liver) in liver transplant patients with hepatitis C virus (HCV) by lowering serum LPS (a protein in the blood that comes from the bacteria in…
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A study for patients with impaired kidney function who will undergo a catheterization procedure using the RenalGuard System

Condition: Kidney Disease
Investigator: Ziad Ali, MD
Status: Closed
Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with…
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A study to observe disease progression and care of patients with Alport Syndrome

Condition: Kidney Disease
Investigator: Gerald Appel, MD
Status: Closed
The purpose of this research study is to understand the way Alport Syndrome affects patients kidneys over time. Alport syndrome is a genetic condition that causes damage to your kidneys over time. Currently there is not much information on the disease. Information about how the body is affected by the disease will be collected, along with medical and family…
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Study to evaluate the safety and effectiveness of Fibrin sealant during open surgeries

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly…
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Study to Evaluate Performance of LifePort Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT)

Condition: Transplant / Liver Transplant
Investigator: Adam Griesemer, MD
Status: Closed
This is a prospective, randomized, multi-center, controlled study for subjects with end stage liver disease who require a liver transplant, comparing whole liver preservation via hypothermic machine perfusion (HMP) using the LLT System with Vasosol with livers preserved via static cold storage (which is standard of care). During Hypothermic Machine…
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A study for patients with Focal Segmental Glomerulosclerosis (FSGS) using study drug Acthar

Condition: Kidney Disease
Investigator: Wooin Ahn, MD
Status: Closed
Focal Segmental Glomerulosclerosis (FSGS) is a disease in which your kidneys allow an excess amount of protein in your urine. Too much protein in the urine (also called proteinuria) is a medical condition called nephrotic syndrome. The purpose of this clinical trial is to evaluate the safety and effectiveness of the study drug, Acthar, in adult patients…
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