This study aims to investigate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared to the standard of care TAE/cTACE to treat a tumor by reducing or completely closing off the arterial blood supply to the tumor. The Instylla HES is an experimental treatment. Subjects will be evaluated for 180 days following the embolization procedure. At each visit, subjects will be asked to complete at least one quality of life questionnaire, undergo a physical assessment (vitals only), blood test to check blood cell levels, and follow-up tumor imaging. Throughout the duration of the study, subjects will be evaluated for complications or side effects that may be related to the procedure and/or Instylla HES device. This study will be conducted at up to 20 sites in the U.S. with additional sites outside of the U.S. It is anticipated that the full investigation will take approximately 2 years.
To assess the safety, tolerability and effects of SBI-101 therapy in COVID-19 subjects with acute kidney injury (AKI) receiving renal replacement therapy. The study product is a device that is added to the dialysis machine and is being developed by Sentien Biotechnologies. Not everyone will receive the study product. A total of 8 subjects will receive the study product and 4 subjects will receive their standard of care treatment. The study product, called SBI-101, is a device that is added to the dialysis machine. Inside the device are human mesenchymal stromal cells (MSC). These cells do not enter your blood. The study duration is approximately 6 months.
Systemic lupus erythematosus (SLE) also known as lupus is a complex autoimmune disorder where the immune system attacks itself instead of external pathogens that can cause disease like bacteria or viruses. The large majority of SLE patients are women. The purpose of this study is to better understand how SLE affects overall patient health in women and expression of genes linked to the development of SLE. Part of this study involves collection of a blood sample at a single visit to test expression of genes linked to SLE. This study will compare demographic and clinical characteristics and genetic differences among women with SLE from three racial/ethnic groups. Better understanding of racial/ethnic differences in health and genetic expression of SLE could help reduce poor disease outcomes such as kidney or heart disease. Results will help us learn more about differences in SLE health across different racial/ethnic backgrounds and will guide medical care.
The study is an open-label study to determine the safety and efficacy of VX-147-101 in subjects who have APOLI dependent FSGS. The study comprises three periods: screening, treatment, and follow-up. The study includes a screening visit to determine if you have the APOLI gene. Participation in this study will last approximately 17 weeks. Participants may choose to participate in an off-treatment observation for up to 12 additional weeks.
The purpose of this study is to test to see if you have a certain genetic mutation (changes in DNA) so we can learn more about kidney disease. The study involves one blood and saliva test and takes about 30 minutes. The blood test is to see if you have genetic changes in your DNA of a protein called APOL1. People who have this gene mutation may be at risk of losing their kidney function faster than others. The test won't cost you anything. In fact, if you decide to participate, you will be compensated $45. You should know that the test used to determine if you have an APOL1 genetic mutation is not FDA approved, however the FDA has approved this test for research purposes. If you were to participate in this study and take the blood test, and the result indicated you have this mutation, there may be an opportunity in the future to volunteer in an additional research study where you will receive the treatment. This treatment is designed by Vertex, especially for people with kidney disease from APOL1 mutation.
Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.
A device called the "Liposorber LA-15 System" has been approved by the
United States Food and Drug Administration for treating kids with focal
segmental glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used,
but the kidneys are still working okay. It can also be used if the subject
has had a kidney transplant and the FSGS comes back after the
transplant. Although the Liposorber System can be used for FSGS, we
are not sure how well the Liposorber System works. So, we are doing this
study to find out how well the treatment works in adults.
In this research study, there will be up to 5 adults who have FSGS
enrolled at MUSC. Subjects will come back for up to 12 treatments over 9
weeks and then 5 visits to their study doctor over the next 2 years.
The study is using cemdisiran compared to placebo injections to determine the safety and efficay of cemdisiran in treating IgA Nephropathy. The study includes a screening period (up to 90 days), 8 month treating period, and 52 week Open Label extension period. Injections occur monthly during the treatment period. Patients will be randomized 2:1 to the cemdisiran or placebo arms.
This study will use a new investigational study drug called OMS721 in people with Immunoglobulin A (IgA) Nephropathy. OMS721 is an antibody, which is a type of protein that can bind to substances in the body. OMS721 is being studied because it blocks a key enzyme (a protein that causes specific chemical changes in the body) in the blood that may be responsible for causing the damage in IgA Nephropathy.
The study is approximately 23 visits over a period of 3 years. The study drug is administered via a 30-minute intravenous infusion once a week for 12 weeks. You will then be evaluated to determine your response to the drug and followed-up with regularly. Possible re-treatment is determined by the study doctor.
The InterGraft Vascular Venous Anastomotic Connector (VIG) was developed for minimally invasive anastomosis (connection) of a vein to a standard, currently sold synthetic graft for hemodialysis. The VIG is designed with a nitinol (metal) frame that is covered with a plastic material called expanded polytetrafluoroethylene, or ePTFE. The ‘vein end' of the VIG is placed within the vein using a special catheter delivery system that is inserted into the vein through a small needle puncture. The ‘graft end' of the VIG is fitted into the graft that is placed under the skin using standard methods. The purpose of this research study is to determine the safety and effectiveness of InterGraft Venous Anastomotic Connector for connecting a hemodialysis graft to a vein.