Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(siplizumab) Compared to Anti-Thymocyte Globulin (rATG), as Induction Therapy in de novo Renal Transplant Recipients

This study is for adults who have recently received a kidney transplant. Researchers are testing a new medicine called TCD601 (siplizumab) to see if it's a safe and effective way to help the body accept the new kidney. This new medicine will be compared to a standard treatment called rATG (anti-thymocyte globulin). The main goals are to check for any side effects and to understand how the medicine works in the body. They will also look at how well the kidneys are working. By doing this, the researchers hope to find better ways to help kidney transplant patients live healthier lives and prevent their bodies from rejecting the transplanted organ.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Itb-Med AB

Enrolment target

Start

07 Feb 2024

Renal Transplantation

What is this study about?

This study is designed for adults who have recently had a kidney transplant. When you receive a new kidney, your body's immune system might try to reject it because it sees the new organ as 'foreign'. To prevent this, you're usually given medicines to calm your immune system. This study is testing a new medicine called TCD601, also known as siplizumab, to see if it can help stop this rejection.

The main aim is to understand if TCD601 is safe to use and how well your body handles it. It will be compared to a treatment that's already commonly used for new kidney transplant patients. The researchers will be carefully monitoring participants for any side effects and observing how the new medicine affects the immune system and the function of the transplanted kidney.

By comparing TCD601 to current treatments, scientists hope to learn if this new medicine could be another effective option to help kidney transplant recipients live long, healthy lives with their new kidneys. This is an important step in finding potentially better ways to support people after a kidney transplant.

Key takeaways

This study is testing a new medicine (TCD601) for kidney transplant patients.
It aims to see if the new medicine is safe and helps prevent kidney rejection.
The new medicine is being compared to a standard treatment.
Participation lasts 12 months and involves regular check-ups and blood tests.
Your safety and well-being are a top priority throughout the study.

Who may be eligible?

This study is looking for adult patients who have recently received a kidney transplant. You must be at least 18 years old to take part.

There might be other specific health requirements or conditions that would mean you can or cannot join. For example, your overall health and other existing medical conditions will be considered. Also, you would need to be able to attend all the scheduled appointments and follow the study instructions carefully.

If you are interested, a member of the study team or your doctor would discuss all the detailed requirements with you to see if this study is a good fit for your situation.

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?
Have you recently had a kidney transplant?
Are you able to attend regular clinic visits?
Do you generally feel well enough to participate in a study?
Are you willing to receive either the new or standard treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the new medicine, TCD601, or the standard treatment, rATG. This means a computer decides which group you're in, like flipping a coin. You'll also receive other standard medications like prednisolone, paracetamol, and possibly others commonly used after a transplant.

Over a period of 12 months, you'll have regular visits to the clinic. At these visits, doctors and nurses will keep a close eye on your health and your new kidney. This will involve regular blood tests to check how your kidney is working, to look for any side effects, and to see how the study medicines are affecting your body. You'll also have physical examinations and your vital signs (like blood pressure and heart rate) checked. The total duration of the study participation is 12 months, with follow-up after the main treatment period.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment that could be more effective or have different side effects than existing treatments for kidney transplant. However, as with any medical study, there are potential risks. You might experience side effects from the study medicines, which will be carefully monitored. There's also the chance that the new medicine might not be more effective than current treatments. Your safety and well-being are the research team's top priority, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Sweden
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Unverified
Spain
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Unverified
Austria

Common questions

What is the new medicine being tested?

The new medicine is called TCD601, also known as siplizumab. It's being tested to help prevent your body from rejecting a new kidney.

Why is this study important for kidney transplant patients?

It's important because it could lead to new or better ways to prevent the body from rejecting a new kidney, helping patients live healthier lives after a transplant.

Will I know which treatment I'm getting?

In this specific study, it's 'open-label', which means both you and the study team will know whether you are receiving the new medicine or the standard treatment.

How long will I need to be in the study?

Your participation in the main part of the study will last for about 12 months, with follow-up after that.

Are there any costs for participating?

You will not have to pay for the study medications or study-related tests and visits. Any travel costs might be reimbursed, but you should check this with the study team.