Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study is an ongoing part of an earlier trial. It's designed to check the long-term safety and how well a new treatment called tegoprubart (AT-1501) works for people who have received a kidney transplant. Researchers are comparing it with a common medication called tacrolimus, which is used to stop the body from rejecting the new kidney. The main aim is to see if tegoprubart can help transplanted kidneys continue to work well over a long period. Participants in this study will have already taken part in a previous related study and will continue the treatment they were on, either tegoprubart or tacrolimus.
At a glance
What is this study about?
When someone has a kidney transplant, their body's immune system can sometimes see the new kidney as foreign and try to attack it. This is called rejection. To prevent this, patients need to take special medicines that help calm down their immune system. This study is looking at a new medicine called tegoprubart (also known as AT-1501) and comparing it with a widely used medicine called tacrolimus.
The main goal of this particular study is to understand the long-term effects of tegoprubart. This means looking at how safe it is over time and how well it helps keep the transplanted kidney working properly. It's an extension of an earlier study, so participants will have already started one of these treatments.
By continuing to follow these patients, doctors can gather important information about how these treatments work over many years. This helps them understand which treatments are best at preventing kidney rejection and keeping transplant patients healthy.
Key takeaways
- This study evaluates two medicines for kidney transplant patients.
- It's an extension of a previous study, focusing on long-term safety and effectiveness.
- The treatments are tegoprubart (new drug) and tacrolimus (standard drug).
- It helps doctors understand the best ways to prevent kidney transplant rejection long-term.
- Participants must have completed a prior related study.
Who may be eligible?
To be considered for this study, you must have already taken part in a previous related study and completed it successfully. You will need to understand what the study involves and be willing to give your written permission to participate.
It's important that you are not involved in any other medical studies at the same time. For women, you must be past menopause or have had a surgical procedure that prevents pregnancy. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception throughout the study and for 90 days after your last dose. Men with partners who could become pregnant also need to agree to use effective contraception and not donate sperm for 90 days after their last dose.
You cannot join if you are unwilling to follow the study's rules, or if you had to stop treatment in the previous study for any reason. If you are pregnant or breastfeeding, you also won't be able to participate.
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.
- Have you already completed the previous related study and been offered entry into this one?
- Are you between 18 and 100 years old?
- Are you able to understand the study information and give your consent?
- Are you currently not pregnant or breastfeeding?
- Do you agree to use effective contraception if you or your partner could become pregnant?
What does participation involve?
If you join this study, you will continue with the same medication (either tegoprubart or tacrolimus) that you were receiving in the previous study you participated in. The study is designed to follow you for a long period to observe the long-term effects of your treatment.
You will have regular check-ups and appointments with the study doctors. These visits will involve assessments to monitor your kidney function, general health, and any potential side effects of the medication. The exact number and timing of visits will be detailed by the study team, but they are crucial for gathering all the necessary information. The total duration of your participation will depend on the study design, as it's an 'extension' study meaning it follows on from previous research.
Potential risks and benefits
Locations (43)
- University of California Los AngelesVerified postcodeLos Angeles, United States
- Keck School of Medicine of USCVerified postcodeLos Angeles, United States
- University of California, Irvine Medical CenterVerified postcodeOrange, United States
- University of California, Davis Medical CenterVerified postcodeSacramento, United States
- Jacobs Medical Center at UC San Diego HealthVerified postcodeSan Diego, United States
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States
- Tampa General HospitalVerified postcodeTampa, United States
- Emory University HospitalVerified postcodeAtlanta, United States
- Augusta UniversityVerified postcodeAugusta, United States
- University of ChicagoVerified postcodeChicago, United States
- Loyola University Medical CenterVerified postcodeMaywood, United States
- University of Kansas Medical CenterVerified postcodeKansas City, United States
Common questions
What is the main purpose of this study?
The main purpose is to see how safe and effective a new drug called tegoprubart (AT-1501) is over a long time, compared to a standard drug called tacrolimus, for people with kidney transplants.
Who can take part in this study?
Only people who have already finished a specific previous study and are adult kidney transplant recipients (aged 18 to 100) are eligible.
What medications are being used in the study?
Participants will continue to receive either tegoprubart (AT-1501) or tacrolimus, depending on what they were taking in the previous study.
Will I have to pay to be in the study?
Clinical trials generally cover the cost of study-related medications and visits, but this will be fully explained before you agree to participate.
What happens if I want to stop participating?
You can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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