Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery

This research study is looking at a new medicine called TIN816. It's designed for adults who are having heart surgery and might be at risk of their kidneys getting damaged afterwards. Doctors call this 'acute kidney injury'. The study will compare TIN816 to a 'placebo', which looks like the medicine but contains no active ingredients. This helps researchers understand if any changes are due to TIN816 itself. They'll be checking how safe the medicine is and if it helps prevent kidney problems or makes them less severe. The main focus is on changes in a kidney function marker called 'creatinine' in the first few days after surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

06 Aug 2024

Acute kidney injury

What is this study about?

When you have major surgery, especially on your heart, there's a small chance your kidneys might get a bit stressed and not work as well as they should for a while. Doctors call this 'acute kidney injury'. This study is investigating a new medicine, TIN816, to see if it can help prevent or reduce this problem in adults undergoing heart surgery.

The research team is keen to find out if TIN816 is safe to use and if it can protect your kidneys. They will be comparing people who receive TIN816 with those who receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. This is a standard way to test new medicines, as it helps doctors understand if the medicine itself is causing any effects, rather than other factors.

Over the course of the study, the researchers will be carefully monitoring participants. They'll check your kidney function by looking at blood tests, especially a marker called 'creatinine'. They will also track your general health, vital signs, and any side effects. The goal is to see if TIN816 can make a real difference in preventing kidney complications after heart surgery.

Key takeaways

This study tests a new medicine (TIN816) to prevent kidney injury after heart surgery.
It compares TIN816 with a placebo (a dummy medicine).
It's for adults 18 and over having heart surgery.
Researchers will check kidney function, safety, and health over several weeks.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is for adults aged 18 or older who are scheduled to have heart surgery. Both men and women can take part.

Because this is a specific type of study, there will be certain health conditions or medicines that might mean you can't join. For example, if you already have significant kidney problems, or other serious health issues, the study might not be suitable for you.

The research team will carefully review your medical history to make sure the study is safe and appropriate for you. They will explain all the requirements in detail.

Quick self-check

Are you 18 years old or older?
Are you scheduled for heart surgery?
Do you understand that you might receive a placebo?
Are you able to attend regular follow-up appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll receive either the new medicine, TIN816, or a placebo, given as an injection or through a drip. Neither you nor the doctors treating you will know which one you are receiving – this is called 'blinded' and helps keep the results fair.

You'll have regular check-ups, including blood tests to check your kidney function and general health, vital signs (like blood pressure), and physical examinations. The researchers will also ask about any side effects you might experience. These checks will happen from when you start until the end of the study. The most intensive monitoring for kidney function will be in the first six days after your surgery, but your safety and health will be followed for a longer period, generally up to 30 or 90 days, to see if any kidney issues develop. The research team will give you a detailed schedule of visits and what each involves.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, such as contributing to medical knowledge that could help future patients. You would also receive close medical attention throughout the study. However, there's no guarantee that TIN816 will help your kidneys, and there's a chance you might experience side effects from the medicine, just like any other treatment. The research team will explain all known or potential risks in detail. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

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Spain
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Germany
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Czechia
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Belgium
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Estonia
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France
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Hungary

Common questions

What is 'acute kidney injury'?

It's when your kidneys suddenly stop working as well as they should. It can happen after major surgery like heart operations.

What is a 'placebo'?

A placebo looks like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your doctor will know. This is to ensure the study results are as fair and accurate as possible.

How long will I be in the study?

The main part of the study involves monitoring kidney function for about six days after surgery, but your health will be checked for up to 30 or 90 days in total.

What is 'creatinine'?

Creatinine is a waste product in your blood. Doctors measure it to see how well your kidneys are working.