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…
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…
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…
Ovaprene, is an experimental monthly non-hormonal intravaginal contraceptive being developed as a possible new method of birth control. It consists of a round piece of woven material surrounded by a soft, flexible rubber ring. The ring itself is made of a silicone rubber combined with the following ingredients: ferrous gluconate (a type of iron), Vitamin C…
The study is looking to evaluate levonogestrel butanoate as a possible new long-acting injectable for birth control. Levonogestrel butanoate is a type of hormone called progestin that has a long history of clinical use in a variety of birth control methods (e.g. pills, intrauterine devices, implants) and its efficacy and safety are well recognized. This…
The purpose of the study is to determine if the drug, CAEL-101 in combination with plasma cell treatment improves overall survival for patients who are diagnosed with stage 3b of AL amyloidosis. Patients who participate in this study will receive CAEL-101 as well as plasma cell treatment or Placebo as well as plasma cell treatment to compare the effects.
The purpose of the study is to determine if the drug, CAEL-101 in combination with plasma cell treatment improves overall survival for patients who are diagnosed with stage 3a of amyloid light chain (AL) amyloidosis. Patients who participate in this study will receive CAEL-101 as well as plasma cell treatment or Placebo as well as plasma cell treatment to…
If you are a woman between the ages of 18 and 35, are pre-menopausal, sexually active and do NOT wish to become pregnant, you are invited to see if you may qualify for a research study. The purpose of this research study is to test the effectiveness of an investigational oral birth control pill. If you qualify, you will receive investigational study…
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 safety and effectiveness of an antibody drug (STI-6129) in patients with AL amyloidosis that has returned or has not responded to treatment (relapsed/refractory). The study drug (STI-6129) will be given in 3 injections through a needle, into a vein as an intravenous (IV), with 21 days between each injection.
This is a study looking to evaluate how well a new hormone-releasing Intrauterine Contraceptive called LevoCept works in healthy, sexually active women. The study will consist of 6 study visits including a screening visit prior to enrollment and monthly telephone calls over the course of a year. The study visits will vary but mostly consist of physical and…
Columbia University is conducting a contraceptive clinical trial looking at two intrauterine devices, one of which is investigational. Pre-menopausal women ages 16-40 who are generally healthy, sexually active, at risk for pregnancy, and are not at risk for sexually transmitted infections may qualify.
The purpose of this study is to assess the effectiveness of AG200-15 which is an investigational birth control patch. AG200-15 is an investigational birth control patch being developed for use by women who wish to use a skin patch to prevent pregnancy. It contains LNG (levonorgestral) and EE (ethinyl estradiol), which are female sex hormones and are active…
This study will look at the safety and effectiveness of a new hormonal IUD. This IUD is a small device that a clinician will place in your uterus. It contains a progestin (a hormone) that releases a small amount of hormone to prevent pregnancy. Once the device is in, you will come in for periodic study visits over the course of a year.
The purpose of this study is to evaluate the efficacy and safety of ION-682884 given for 24 months in patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN) also known as Familial Amyloid Polyneuropathy (FAP), and determine if it can help people with mild or moderate polyneuropathy. To be in this study you must have FAP and be…
This study is studying the effectiveness and safety of a new birth control pill. The pill contains two hormones, drospirenone (a progestin) and estetrol (an estrogen), which combine to prevent pregnancy. Scientists think that estetrol may be safer and have more benefits than other estrogen hormones. The study lasts about one year, and you will come in for 7…
The purpose of this study is to evaluate whether study drug NEOD001 will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts. This study will also evaluate whether NEOD001 improves the function of subjects' organs that have been affected…
The purpose of this study is to find out if MLN9708 plus dexamethasone improves against systemic light chain amyloidosis better than the physicians choice chemotherapy treatment. Physicians choice chemotherapy treatment is a treatment regimen that is commonly used to treat amyloidosis patients. The study will also determine if MLN9708 plus dexamethasone can…
HELIOS-A is a global Phase 3 randomized, open-label study designed to evaluate the safety and efficacy of ALN-TTRSC02 in adult patients with hATTR amyloidosis experiencing neurologic symptoms brought on by the disease. The study will also evaluate any changes in quality of life experienced by study participants. ALN-TTRSC02 utilizes the mechanism of RNA…
The unintended pregnancy rate is rising despite increased availability and use of different types of emergency contraception (EC) pills. Few studies have addressed reasons for EC failure, yet such an investigation may allow researchers to better understand if EC can be used more successfully.Recently studies have shown that EC failure rates are higher in…
This is a research study for subjects that have been previously treated for systemic light chain (AL)amyloidosis (a disease in which abnormal protein deposits can damage organs and tissues in your body) and nowrequire further treatment. The main purpose of this study is to evaluate the safety and determine the maximum tolerated dose of aninvestigational new…
We are asking you to participate in this research study because you are a woman of child-bearing age or potential and interested in using an intrauterine device (IUD) for birth control for up to 5 years.
The purpose of this study is to test for any good and bad effects of the study drug called isatuximab. Isatuximab may or may not improve your AL amyloidosis, but it could also cause side effects. Isatuximab is not approved by the Food and Drug Administration (FDA). Isatuximab has been shown to have good effects in some patients with recurring multiple…
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…
There are over 62 million US women in their child-bearing years, ages 15-44. Thirty-eight million use some form of contraception which included permanent sterilization (tubal ligation or vasectomyin male partner), contraceptive implants, intrauterine devices, injections, pills, patches, vaginal spermicides, and behavioral methods such as coitus interrupts…
The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment. Bendamustine is currently approved by the Food and Drug Administration (FDA) for treatment of chronic lymphocytic leukemia (CLL) and is under clinical development in the United States for the…
Do You Have a Mirena IUD? You may qualify for a study on the extended use of the Mirena IUD! You may qualify if you are 18 to 33 years old and had your Mirena placed in 2013. Compensation available for time and effort. Find out if you qualify!
The purpose of this study is to see if daratumumab when given with three other drugs cyclophosphamide, bortezomib (VELCADE) and dexamethasone is useful for treating patients with Amyloid light chain Amyloidosis (also known as AL Amyloidosis). The study will look at what happens (both good and bad) when daratumumab is given with these three drugs compared to…
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…
The purpose of this study is to find out how safe and effective investigational birth control pill, LF111 may be as a contraceptive, how it affects women's menstrual bleeding patterns, and how long LF111 stays in women's bodies. Participants will take the new experimental birth control pill for one year, and will come to the medical center for 8…