Study Treatment and Timeline
How does the treatment work?
Siplizumab: works by reducing the number and activity of white blood cells, the part of the immune system that causes rejection. This may help lower the risk of your body rejecting your new kidney.
Nulojix (belatacept): a prescription medicine used to prevent rejection in people who have received a kidney transplant. Compared to the standard treatment, belatacept given from the time of transplant results in better kidney function over time, but can lead to more kidney rejections.
The Combination: By combining siplizumab with belatacept at the time of transplant, there is the potential for a lower risk of kidney rejection than with belatacept alone while preserving kidney function compared to standard treatment.
What will happen if I participate in this study?
The study will begin with you signing a consent form and procedures will be carried out in the following periods:
Screening Period: After informed consent, the study doctor will confirm that you can enter the study.
Treatment Period: If you qualify for the study, you will start your treatment on the day you receive your kidney transplant (Day 0) and will attend follow-up study visits for about 1 year. During this period, you will receive study medication and have tests and procedures conducted to gather data.
Frequently Asked Questions
The aim of the study is to evaluate the new combination treatment of siplizumab with belatacept. This is an experimental treatment that has not been tested with this combination of medications before so it is not known if you will benefit from the treatment. The information gained may help other patients who are receiving a kidney transplant in the future.
There is no cost to participate in the study, the drugs and procedures that are part of the study will be paid for or provided by the study sponsor, ITB-MED. However you and your insurance will still be responsible for the medical care costs that are normally part of the kidney transplant process.
The combination of siplizumab and belatacept is not an approved treatment. There are known risks for each drug but the risks associated with this combination are unknown. This will be explained in detail by the study doctor during the consent process.
Your participation in this research study will last approximately 12 months and will include regular follow-up visits at the hospital or outpatient clinic. Many of these visits are considered routine and would occur even if you were not in the research study.
A general background to kidney transplantation is provided by the National Kidney Foundation. Click the link below to visit their website:
Visit kidney.org