The enVISion research study is evaluating an investigational steroid-free drug called VIS649 for Immunoglobulin A Nephropathy (IgAN).
You may qualify to participate in the enVISion study if you:
- Are at least 18 years of age
- Have been diagnosed with IgAN (confirmed by a kidney biopsy)
- Have been taking a stable, maximally tolerated dose of certain blood pressure medications for the last 3 months (or are unable to tolerate these medications)
- Have not taken systemic steroids in the last 6 months
- Have not taken 2 or more medications that suppress your body’s immune system in the last 2 years
- Are willing and able to use study-provided supplies to collect your urine for 24 hours and then return it to the study nurse
Other criteria will be reviewed at the first study visit to determine if you are able to participate in the study.
The enVISion study lasts up to 17 months and requires about 18 visits to a local study clinic (we have sites worldwide) for study-related tests and procedures. All study-related office visits, medical procedures, laboratory tests, and study intervention are provided at no cost to qualified participants.
Please watch our video to learn more about IgAN and the enVISion study to see if it could be right for you.
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Currently, there are no drugs that are specifically approved for the treatment of IgAN. Often it is treated with steroids to reduce inflammation or drugs that suppress the entire immune system.
VIS649, the investigational drug being tested in the enVISion study, is a monoclonal antibody, which is a type of protein made in the laboratory that can bind to a substance in the body. It is designed to specifically target the cells in the body that produce IgA. It attaches to those cells and blocks the production of IgA, including the abnormal IgA that causes IgAN.
If you qualify and decide to participate in the enVISion study, you will be randomly assigned (like rolling dice) to study intervention with 1 of 3 doses of VIS649 or placebo (an inactive substance that looks like the investigational drug). Each participant will have a 3 in 4 chance of receiving the investigational drug, and you do not get to choose which study intervention you receive. The study intervention is administered as an intravenous infusion once a month in the study clinic over a 12-month period.
About Clinical Studies
What is a clinical research study?
A clinical research study (also known as a clinical trial) is designed to evaluate how safe and/or effective an investigational drug is in treating a specific disease or condition. The results of clinical studies help regulatory agencies decide if an investigational drug should be made available to patients. Clinical studies are the only way we can develop new and better treatments and improve patient care.
How are my rights protected?
Every clinical study is reviewed by an independent review board (IRB) or ethics committee (EC), which helps to ensure that the study is conducted safely and that the rights of study participants are protected. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study.