This multi-center, prospective, randomized, clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of the SelfWrap, a bioabsorbable perivascular wrap, for supporting surgically-created AVFs and using them for dialysis.
This study will involve approximately 200 participants. Half of the subjects in this trial will receive AVFs supported by the SelfWrap, while the other half will receive a traditional AVF alone. Participants will be followed for a duration of 36 months.
This is a randomized, single-blind controlled, two group, multicenter trial
preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) –
Acute Kidney Injury (HRS-AKI) to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients.
We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.
This is a research study to evaluate the safety and effectiveness of Niyad (nafamostat mesylate) as a blood thinner used during continuous renal replacement therapy (CRRT). CRRT is a standard treatment much like dialysis that is used to temporarily take the place of kidney function when one's kidneys are injured. Like your kidneys, CRRT helps to clean your blood and remove waste products.
Niyad is experimental which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). There is no guarantee that you will receive direct benefit as a result of your participation in this study. Possible benefits of Niyad include preventing your blood from clotting the dialysis filter so that the CRRT machine works more effectively and it also may reduce your need for a transfusion. The study results may help people in the future.
Participation voluntary and is expected to last up to 28 days. The length of time you may be exposed to Niyad is up to 7 days and safety assessments may last up to 28 days.
There will be no additional cost to you for procedures required in this research study. All routine clinical care that you would have undergone without participation in the study, including testing and procedures, will be billed to you/your insurance company. All study-related tests and procedures will be paid for by the Sponsor.
Some insurance plans will not pay for these services for people taking part in research studies. You will be responsible for any charges that your insurance does not cover including co-payments and deductibles.
The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.
Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.
Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.
An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.
Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.
The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.
Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.
This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.
This is a 12-month, randomized study that involves pre-transplant procedures, a kidney transplant, and post-transplant procedures. After kidney transplantation, every patient, whether in a research study or not, must take immunosuppressive medications to prevent their immune system from rejecting their new kidney. A rejection can harm your new kidney which can lead to lower kidney function. The purpose of this research is to test the safety and effectiveness of siplizumab for kidney transplant patients. Study participants who receive the new study treatment will be compared to participants receiving the most common approved immunosuppressive treatments referred to as "standard of care". You will be randomized into either the study group or the "standard of care" group, like flipping a coin. Because this is a research study, siplizumab will only be given to you during the research study as in infusion treatment. Siplizumab is an investigational medication, which means it has not been approved by the Food and Drug Administration (FDA) and is currently not "on the market" in any country. The potential risks of siplizumab are infusion reactions, inflammatory reactions, immunosuppression, and infections. The benefits of the study treatment are unknown but are suspected to decrease chances of rejection and increase the chance of effective kidney function. An alternative to this study would be to not participate and pursue the standard of care treatment after your kidney transplant.
The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.