Active not recruitingOBSERVATIONAL

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

This study is a long-term check-up for people who previously took part in an earlier study looking at a special treatment called TX200-TR101. This treatment was for people who had a kidney transplant to help prevent their body from rejecting the new kidney. The researchers want to follow these patients for up to 15 years after they received the treatment. The main goal is to carefully observe and collect information about their health over many years, focusing on whether the treatment was safe and if their bodies continued to handle it well. It’s important to understand how new treatments affect people in the long run, and this study helps gather that vital information.

At a glance

Status

Active not recruiting

Sponsor

Sangamo Therapeutics

Enrolment target

Start

15 Aug 2023

Estimated completion

11 Jun 2039

Kidney Transplant Rejection End Stage Renal Disease

What is this study about?

Imagine you've had a kidney transplant, which is a life-changing operation. Sometimes, your body can try to reject the new kidney, meaning it sees it as foreign and tries to fight it off. In the past, some people took part in a study for a special treatment called TX200-TR101, designed specifically to help prevent this rejection.

This current study, called STEADFAST Long Term, is a way for doctors to keep an eye on those people who received that treatment. It's not about giving new treatment; it's about checking in with them over a long period. The researchers want to understand how their bodies are doing for many years – up to 15 years – after they had the original treatment. They are particularly interested in the long-term safety of the treatment and if people continue to feel well.

By carefully observing participants and gathering information over time, doctors can learn a lot. This helps them understand the lasting effects of treatments like TX200-TR101, which is crucial for improving care for future kidney transplant patients. It's all about making sure that new therapies are not only effective but also safe in the long run.

Key takeaways

This study is a long-term check-up for people who had a kidney transplant and a special treatment (TX200-TR101).
It aims to understand the treatment's safety and effectiveness over many years, up to 15 years.
You won't receive new treatment in this study; it's about observation.
Participation mainly involves giving a blood sample.
Your contribution helps improve future kidney transplant care.

Who may be eligible?

This study is specifically for people who have already been part of an earlier study called TX200-KT02. In that previous study, you would have received a kidney transplant and the special treatment (TX200-TR101). It doesn't matter if you finished the previous study or had to leave it early; you might still be able to join this long-term follow-up.

To be eligible, you also need to be willing to sign a consent form. This form explains everything about the study in detail, and by signing it, you show that you understand and agree to take part. You must be able to do this yourself, in line with your local hospital's rules. If you meet these conditions, and you are between 18 and 72 years old, you might 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.

Were you previously in the TX200-KT02 study?
Did you receive a kidney transplant in that previous study?
Are you between 18 and 72 years old?
Are you able to provide written agreement to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's mostly about keeping in touch with the researchers. You won't be given any new medication as part of this study. Your main involvement will be providing a blood sample when requested.

This is an observational study, which means the researchers will simply be observing your health journey over time. The study aims to follow participants for a very long time – up to 15 years after they received their original treatment. You won't have frequent clinic visits specifically for this study, but ongoing contact and occasional checks will help gather important long-term safety information.

Potential risks and benefits

The main benefit of taking part is contributing valuable information that could help improve kidney transplant care for many others in the future. By sharing your long-term health experience, you help doctors understand how treatments like TX200-TR101 truly impact people over many years. The main risk involved is the slight discomfort and very small chance of bruising from a blood sample. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Leuven
Verified postcode
Leuven, Belgium
University Medical Center Groningen
Verified postcode
Groningen, Netherlands
Leiden University Medical Centre
Verified postcode
Leiden, Netherlands
Erasmus MC, University Medical Center
Verified postcode
Rotterdam, Netherlands
Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom

Common questions

What is the study called?

The study is called STEADFAST Long Term, and it's looking at a treatment called TX200-TR101.

What is the main purpose of this study?

The main purpose is to check on the long-term safety and how well people tolerate the TX200-TR101 treatment for up to 15 years.

Do I get any new medicine in this study?

No, this study does not involve giving you any new medicines. It's purely for observation.

How long will I be followed in the study?

You could be followed for up to 15 years after you had the original TX200-TR101 treatment.

What will I have to do if I join?

Mainly, you will be asked to provide a blood sample, so doctors can monitor your health over time.