This study is testing whether a new investigational medicine called frexalimab can safely and effectively prevent kidney transplant rejection compared to tacrolimus, a standard medication currently used after transplant. Participants will be randomly assigned to receive either frexalimab (given by injection every 4 weeks) or tacrolimus (taken as capsules…
The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be…
The purpose of this research study is to determine whether rosuvastatin is safe and can help people living with cirrhosis lead longer, healthier lives. The study drug, rosuvastatin, is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA). Participants will…
This purpose of this study is to understand the interaction between two different medications, tacrolimus and Paxlovid (nirmatrelvir/ritonavir), in patients who have had a kidney transplant and are being treated by their doctor for COVID-19 infection. Tacrolimus is an oral medication that is used standardly in kidney transplant recipients to prevent…
LCN Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months for a total of 3 years. Some of the visit…
This is a 60-month adaptive to evaluate three siplizumab-based treatment regimens in kidney transplant recipients. The purpose of this research study is to see if the anti-rejection medications that patients normally take after transplant can be reduced or stopped completely by using several medications including the investigational drug siplizumab in the…
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and hepatitis C can be cured. The…
The purpose of this study is to determine if an investigational drug called tegoprubart (also known as AT1501) is safe and effective in preventing rejection in patients who are undergoing a kidney transplant for the first time. Participants will be randomly assigned to tegoprubart or standard treatment with tacrolimusat the time of transplant. If you have…
The Red-C 3131 Study is a phase 3 study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE in adults who have been diagnosed with advanced liver cirrhosis. Adults who have been diagnosed with advanced liver cirrhosis, but who don't yet have HE may be eligible to join. About 466 patients will be enrolled across 200 sites.…
This is a research study to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of inflammation in the process. If you participate, you will receive an experimental medication for your depression named ethyl eicosapentaenoic acid (ethyl EPA), an omega 3 fatty acid. You will…
The goal of this study is to examine how effective and well-tolerated a possible new treatment for individuals who injure themselves frequently will be. All research procedures can be done from home no in-person visits are required. We are studying a minimal-risk form of electrical brain stimulation called transcranial direct current stimulation, or tDCS.…
Kidney transplant patients are at a higher risk for bone fractures compared to the general population. We are doing a clinical trial to examine the effects of 12-months of treatment with denosumab, a monoclonal antibody against RANKL, on bone density and strength as determined by bone imaging and by non-invasive measures of bone activity from blood and…
The purpose of this study is to evaluate the efficacy of the drug OCR-002 for the treatment of an acute hepatic encephalopathy episode in cirrhotic patients requiring hospitalization. Subjects who have been recently hospitalized will potentially receive OCR-002 via infusion on top of their standard care for 5 days. Patients will be assessed 24-hours after…
This study is a double-blind and placebo-controlled study to assess its efficacy of the new drug Lumateperone for patients with Major Depressive Episodes associated with Bipolar I and Bipolar II disorder. Lumateperone is thought to exert its antidepressant effect through interaction with sereotogenic, dopaminergic, and glutamergic neurotransmitter targets.…
We will evaluate the D-cycloserine (DCS) and lurasidone with MRI measurement of brain responses to DCS. DCS is a drug that works on the same brain receptor as ketamine. DCS is not approved by the FDA for bipolar depression. Study participants will receive a dose of lurasidone or placebo in one MRI and a dose of DCS in another, followed by an optional follow…
Subjects who undergo a kidney transplant require long term use of anti-rejection (immunosuppressive)drugs to prevent their body's immune system from attacking and damaging the newly transplanted kidney (rejection).The purpose of this study is to evaluate benefits and risks of two combinations(regimens) of immunosuppressive therapies: Thymoglobulin…
The purpose of this research study is to see if an investigational drug, BB3, is safe and effective forincreasing the amount of urine that a transplanted kidney will produce. An investigational drugis one that is not approved by the United States Food and Drug Administration (FDA). BB3 is agrowth factor-like drug, which means that it can affect cell…
We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. If you participate, you will have two different brain scans (MRI and PET scan). You will also have antidepressant treatment for free. We will then be able to see whether information on the brain scans connects with how people do on the medications. The…
The purpose of this study is to evaluate whether cirrhosis occurs as a result of NASH. NASH is a disease that results when fat accumulates in the liver. GS-6624 is an experimental medication designed to help reverse the scarring process, and the purpose of this study is to see if GS-6624 can reverse the scarring in the liver and heal cirrhosis.
We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of dopamine signaling in the process. If you participate, you will have two different brain scans (MRI and PET scan). You will also have treatment for your depression with an FDA approved medication,…