BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
This research study is testing a new medicine called BIVV020 (also known as SAR445088) for people who have received a kidney transplant. The main goal is to find out if this new drug can help prevent the body from rejecting the transplanted kidney or treat rejection if it's already happening. We call this 'antibody-mediated rejection' or AMR. The study is divided into two groups: one looking at prevention and another looking at treatment. Researchers will also check to see if the drug is safe, how the body handles it, and if it causes an immune reaction. This study is important for improving outcomes for kidney transplant patients in the future.
At a glance
What is this study about?
When someone receives a new kidney through a transplant, their immune system, which usually fights off infections, can sometimes see the new organ as a threat. This can lead to something called 'rejection', where the body tries to attack and damage the transplanted kidney. This specific study focuses on a type of rejection known as 'antibody-mediated rejection' (AMR).
This study is looking at a new investigational drug called BIVV020 (you might also see it referred to as SAR445088). The researchers want to understand if this new medication can either stop this rejection from happening in the first place, or if it can help treat it if it has already started. This is a "Phase 2" study, which means it's still in the earlier stages of testing in people, focusing on whether the drug works and is safe.
The study has two main parts. One part will involve people who are about to receive a kidney transplant, to see if BIVV020 can prevent rejection. The second part will involve people who have already had a kidney transplant and are now experiencing rejection, to see if BIVV020 can treat it. The hope is that this new medicine could offer a new way to help people keep their transplanted kidneys healthy for longer.
Key takeaways
- This study is testing a new drug, BIVV020, for kidney transplant patients.
- It aims to prevent or treat kidney rejection (AMR).
- Participation involves regular check-ups and possibly new medication.
- The study includes adults aged 18 and over.
- There are specific health requirements to join.
- Your health will be closely monitored throughout.
Who may be eligible?
This study is looking for adults aged 18 and over who need a kidney transplant or have recently had one and are experiencing rejection.
To join, you should be preparing to have the standard treatments for your kidney condition. If you're having a transplant, it needs to be from either a living or deceased donor. If you're experiencing rejection, it needs to be an 'active' form of rejection that a doctor has diagnosed. Your body mass index (BMI) should also be 40 or under. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to use effective contraception during the study and for about 49 weeks after your last dose of the study drug.
However, there are reasons you might not be able to join. For example, if your blood type isn't compatible with your donor, or if you have certain active infections like HIV, Hepatitis B or C, or have had tuberculosis. People with a condition called lupus (systemic lupus erythematosus) or those who have recently used similar types of drugs that affect the immune system might also not be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you about to receive a kidney transplant, or have you recently had one and been diagnosed with active rejection?
- Do you have a Body Mass Index (BMI) of 40 or less?
- Are you able to use reliable contraception if needed?
- Do you have any active infections like HIV, Hepatitis B/C, or a history of tuberculosis?
- Are you currently taking part in another clinical research study?
What does participation involve?
If you join this study, it could last for up to about two years. You would receive either the new study drug, BIVV020, or other standard treatments for kidney transplant rejection, depending on which group you're in. These treatments include common medications like Intravenous immunoglobulin (IVIg), Rituximab, Antithymocyte globulin (ATG), Tacrolimus, Mycophenolate, and steroids (corticosteroids). The specific details of what you would take and how often would be explained to you.
Throughout the study, you would have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. This helps the study team understand if the drug is effective, how your body processes it (pharmacokinetics), and if your immune system reacts to it (immunogenicity).
Details about the frequency of visits and specific tests would be fully explained before you agree to participate.
Potential risks and benefits
Locations (27)
- Cedars-Sinai Medical Center- Site Number : 8400100Verified postcodeLos Angeles, United States
- University of California Los Angeles Medical Center- Site Number : 8400103Verified postcodeLos Angeles, United States
- University of California San Francisco - Parnassus Heights- Site Number : 8400001Verified postcodeSan Francisco, United States
- Massachusetts General Hospital- Site Number : 8400007Verified postcodeBoston, United States
- Brigham & Women's Hospital- Site Number : 8400004Verified postcodeBoston, United States
- NYU Langone Medical Center- Site Number : 8400102Verified postcodeNew York, United States
- University of Wisconsin Hospitals and Clinics- Site Number : 8400003Verified postcodeMadison, United States
- Investigational Site Number : 1240101Verified postcodeVancouver, Canada
- Investigational Site Number : 1240001Verified postcodeVancouver, Canada
- Investigational Site Number : 1240002Verified postcodeLondon, Canada
- Investigational Site Number : 1240003Verified postcodeMontreal, Canada
- Investigational Site Number : 2500007Verified postcodeBordeaux, France
Common questions
What is 'antibody-mediated rejection'?
It's a common type of rejection where your body's immune system makes proteins called 'antibodies' that attack your transplanted kidney.
What is BIVV020?
BIVV020 is a new medicine being tested to see if it can stop or treat the body's immune system from rejecting a transplanted kidney.
How long does this study last?
If you take part, your involvement could last for up to about two years.
Will I definitely get the new drug BIVV020?
Not necessarily. Some participants will receive BIVV020, while others will receive standard care treatments, depending on the study group.
What does 'Phase 2' mean for a study?
Phase 2 means the drug is still in earlier stages of testing in people. Researchers are checking if it works well and if it's safe for patients.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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