A NEW RESEARCH PROGRAM
is working to modernize anti-rejection treatment in kidney transplantation.
Learn about a clinical study testing a new investigational drug designed to prevent kidney rejection in people undergoing a transplant.
Study Overview
What is the MODERNIZE 1 clinical study?
Since the 1980s, part of the standard of care for kidney transplantation is a drug called anti-thymocyte globulin (ATG). ATG acts against immune cells to prevent rejection of a transplanted kidney. However, it can also act on other cells and cause additional side effects.
The MODERNIZE 1 study is evaluating an investigational drug called siplizumab to better understand if it could be a safe, effective alternative to ATG.
What is the study drug?
Siplizumab is a type of investigational drug called a monoclonal antibody. It binds to certain cells that are part of the immune system, preventing them from working normally. It is believed that this will help suppress the immune system so that the body is less likely to reject a transplanted kidney.
Taking Part in the Study
What is the MODERNIZE 1 clinical study?
The study lasts about a year and is divided into 4 main parts:
| STUDY PERIOD | DESCRIPTION |
|---|---|
| Screening (up to 4 weeks) | Your medical history will be reviewed, and you will have tests done to see if you can take part in the study. |
| Randomized Study Treatment (up to 4 days) | If you qualify, you will be randomly assigned to study treatment with one of the following: • High dose siplizumab (investigational) • Low dose siplizumab (investigational) • ATG (standard of care) You do not get to choose which study treatment you receive. Neither you nor the study doctor will know which study treatment you receive, unless there is an important medical reason to find out. You will receive study treatment intravenously for up to 4 days while in the hospital. You will remain in the hospital during this time as part of routine care. |
| Follow-up | After hospital discharge, you will attend 6 more visits in the clinic over the next 9 months for study procedures and testing. You will be asked to install a study-specific app on your mobile device and use this app throughout the study to answer study-related questions. |
| End of Study | Approximately 48 weeks after the day of your transplant, you will attend one last in clinic study visit for laboratory tests, questionnaires, and a health check. |
Other Medications
At the start of Randomized Study Treatment, you will begin treatment with several background medications:
tacrolimus, mycophenolic acid, and corticosteroids.
These are considered standard of care immunosuppression medications and are available under different brand names in different countries.
Should I participate in the study?
There is no certainty that you will benefit from taking part in the study. The information collected during this study may help doctors improve care for people in the future who have kidney transplants.
Taking part in a clinical study is completely voluntary. Participation is not required. You can choose to leave the study at any time and for any reason.
Will the study cost me anything?
The study treatment (siplizumab or ATG), study visits, and study-related tests and procedures are provided at no cost to you. Reasonable travel and accommodations for you and a caregiver will be covered through a specialized concierge service that the sponsor is paying for. The study staff can tell you more about this support.
About Clinical Studies
What is a clinical study?
A clinical study is designed to help us learn more about medical devices, drugs, or diagnostic tests. Health authorities use the results of clinical studies to decide if an investigational drug should be made available for use in a particular country.
How are my rights protected?
Every research study is reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC), which helps ensure that the study is conducted safely and that the rights and privacy of study participants are protected. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study.