UC Davis Health Clinical Studies

A Study of the Experimental Cytomegalovirus (CMV) Vaccine (HB-101) in Kidney Transplant Patients

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The purpose of this clinical research study is to see if an investigational anti-Cytomegalovirus (CMV) vaccine known as HB-101 is safe to use and helps patients. The main purpose of this study is find out:  How well HB-101 could protect from significant CMV infections.  The side effects of HB-101. CMV is a common infection that can be dangerous when your defense against commonly mild infections is low. For example, this can happen in patients who receive a kidney from a donor. Most people whose immune system is working well with CMV infection have no symptoms. If any, symptoms are mild illness such as fever, sore throat, fatigue, and swollen glands. However if your immune system is weak, CMV can affect your lung, gut, eye or other organs and can create severe damages. This study involves the use of an new investigational anti-CMV vaccine known as HB-101. HB-101 is a vaccine that is believed to prevent CMV infection after kidney transplant by forming antibodies and stimulating your immune cells against CMV. This vaccine doesn’t contain eggs or mercury. HB-101 contains a Genetically Modified Organism (GMO). The vaccine uses genes from two different viruses, but it can’t reproduce any infectious viruses in your body. The HB-101 vaccine is constructed from parts of a LCMV. The parts of the LCMV used is not alive and cannot reproduce or give you an infection. When HB-101 vaccine is introduced inside your body, it tricks your body in thinking it has CMV. It teaches your immune system to make antibodies to protect you against CMV infection. The HB-101 vaccine is not live and can’t spread in your body or outside your body in the environment.

Biological study, Phase 2
Any, age 18 to 99 years old

A Study of Oral vs Transdermal (through skin patch) Oxybutynin for Post-surgical Bladder Pain and Urgency in Children

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After bladder surgery, most patients have urinary urgency (the feeling of having to urinate). Doctors may give a medication to help treat or prevent this feeling. The medication Ditropan (oxybutynin) relaxes the bladder muscle and is currently given. This research study will test if oxybutynin works better in the oral form (liquid) or given through a skin patch (transdermal). Ultimately, we want to find the best form of the medicine for our patients to feel better after surgery.

Drug study, Phase 3
Any, age 4 to 8 years old

An Exercise Study Testing Muscle Mitochondria (energy production) in Chronic Kidney Disease

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The purpose of this research study is to find out if exercise improves how well the mitochondria work. We also want to know if exercise improves ability to perform physical tasks. Finally, we will also test several components in the blood which may be related to physical abilities. We are doing this research because exercise may improve the overall balance of these components. What we learn in this study may help us to better understand the mitochondria and muscle in people with kidney disease. We hope to use this knowledge to improve their ability to be active and independent.

Behavioral study, Phase 2
Any, age 18 to 75 years old

A Comparison Study of the Experimental Human Acellular Vessel For Dialysis in End-Stage Renal Disease

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This research study is for patients with kidney failure, undergoing hemodialysis with a dialysis catheter. For long term hemodialysis, it's best to create a more permanent and safe route to connect your blood stream to the dialysis machine. There are many ways to do this including surgically implanting a graft (a short piece of tubing). Another option is to surgically connect your artery and vein. This connection is called an autologous arteriovenous fistula or AVF. This study will compare a new investigational graft developed by Humacyte (the Human Acellular Vessel or HAV) with an AVF. This study will compare the ability of the HAV to function as an alternative to AVF for vascular access during hemodialysis.

Biological study, Phase 3
Any, age 18 years or older

A Study of Experimental Gemcitabine Hydrochloride and Cisplatin For Invasive Bladder Urothelial Cancer

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The purpose of this study is to see if some patients with muscle-invasive bladder cancer can avoid surgery to remove their bladder. New research has shown that bladder tumors with changes in the DDR genes are very sensitive to a certain chemotherapy treatment. This treatment is known as dose-dense gemcitabine and cisplatin (ddGC). In this study, we are studying patients whose tumors have a DDR gene mutation. Their bladder tumor has shrunk after chemotherapy. We want to learn if they can keep their bladder and avoid a removal surgery called a radical cystectomy. The study doctors hope to learn whether this approach is better or worse than the usual treatment.

Drug study, Phase 2
Any, age 18 years or older
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