Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called for patients who are at risk of developing after undergoing . Acute kidney injury is a condition where the kidneys suddenly stop working properly, which can happen after major surgeries like those involving the heart. The study aims to evaluate how safe and effective TIN816 is in preventing this condition.

Participants in the study will receive either the TIN816 treatment or a , which is a substance with no active medication. The treatment is given as a powder that is mixed into a solution and administered through an injection or infusion into the veins. The study will monitor the participants’ kidney function by measuring levels of a substance called serum creatinine in the blood, which helps indicate how well the kidneys are working.

The study will take place over a period of time, with regular check-ups to assess the safety and tolerability of TIN816. Participants will be observed for any side effects and changes in their health, including their vital signs and kidney function. The goal is to determine if TIN816 can effectively reduce the risk of acute kidney injury in patients who have undergone cardiac surgery, compared to those who receive the placebo.

1 joining the study

Upon joining the study, the participant will be required to provide signed informed consent. This ensures understanding and agreement to comply with the study requirements.

Participants must be able to communicate effectively with the investigator and meet specific health criteria, including age, weight, and stable vital signs.

2 pre-surgery assessment

Before the surgery, a thorough assessment of renal function will be conducted. This includes ensuring no significant increase in serum creatinine levels and no presence of acute kidney injury (AKI).

The surgery must be a non-emergent open chest procedure with a cardiopulmonary bypass time of at least one hour.

3 treatment administration

Participants will receive either the investigational drug TIN816 or a placebo. TIN816 is administered as a powder for solution, given intravenously.

The dosage of TIN816 is 70 mg, and it is administered as per the study protocol.

4 post-surgery monitoring

After the surgery, participants will be closely monitored for changes in serum creatinine levels up to and including study day 6.

Safety assessments will include monitoring vital signs, conducting physical examinations, ECGs, and laboratory tests.

5 follow-up assessments

Participants will be evaluated for the presence of anti-drug antibodies against TIN816 and any adverse kidney events at day 30 and day 90.

The study will also assess the occurrence of major adverse kidney events, known as MAKE30 and MAKE90, at these time points.

Who Can Join the Study?

You must sign a form agreeing to participate in the study and be able to communicate well with the study team.
You should be a male or female who is 45 years or older.
Your weight should be between 50 kg and 150 kg, and your Body Mass Index (BMI) should be below 40. BMI is a measure of body fat based on your weight and height.
Your vital signs, which include body temperature, blood pressure, and pulse rate, should be within specific ranges. If they are not, the study team may check them up to three times to see if they fall within the required range.
Your kidney function should be stable, with no significant increase in serum creatinine (SCr), a waste product in the blood, by 25% or more compared to a previous test within the last 6 months. You should not have any stage of Acute Kidney Injury (AKI) before surgery.
You must be scheduled for a planned open chest surgery involving a cardiopulmonary bypass (CPB), which is a machine that takes over the function of the heart and lungs during surgery, and the expected time on this machine should be at least 1 hour.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication or its ingredients.
Patients who are currently participating in another clinical trial.
Patients with a known history of chronic kidney disease, which means their kidneys do not work as well as they should over a long period.
Patients who have had a kidney transplant, which is when a person receives a new kidney from a donor.
Patients with severe liver disease, meaning their liver is not functioning properly.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse, which means they have used substances in a way that is harmful to their health.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Gottsegen National Cardiovascular Center	Budapest	Hungary
Herzzentrum Leipzig GmbH	Leipzig	Germany
University Of Debrecen	Debrecen	Hungary
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Tartu University Hospital	Tartu	Estonia
Semmelweis University	Budapest	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Ziekenhuis Oost Limburg	Genk	Belgium
University Of Pecs	Pecs	Hungary
Hopital Beaujon	Clichy	France
University Hospital Ostrava	Ostrava	Czechia
Uiiaqopjeevnewzszwdzj Ejjyf Aqx	Essen	Germany
Iykhxlrrs Fxc Coxhhphr Add Edddgjgrswvj Mdlrimeh	Prague	Czechia
Hatggkyg Ulhckgpwqykkx Dt Ll Pptmlvzf	Madrid	Spain
Gvszjc Unkazaghwk Fvnpniynt	Frankfurt	Germany
Hhyxhxvd Uhvkobrhwizqg Hxhuzhuv Tghgl y Ppeopd Iqmadbbv Cvpkar drbkhrlkrluomsqpu (yert	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.03.2023
Czechia	Not recruiting	03.03.2023
Estonia	Not recruiting	03.03.2023
France	Not recruiting	03.03.2023
Germany	Not recruiting	03.03.2023
Hungary	Not recruiting	03.03.2023
Spain	Not recruiting	03.03.2023

Trial locations

Investigated drugs:

Tin816

TIN816 is a medication being studied to see if it can help protect the kidneys in adults who are at risk of kidney injury after having heart surgery. The trial is looking at how this medication affects the levels of a substance in the blood called creatinine, which can indicate how well the kidneys are working.

Acute Kidney Injury – Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. This condition can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. Symptoms may include decreased urine output, swelling due to fluid retention, and fatigue. The progression of acute kidney injury can vary, with some cases resolving quickly while others may lead to more severe kidney damage. Monitoring and managing the underlying causes are crucial to prevent further complications.

Trial ID:

2024-511621-64-00

Protocol code:

CTIN816A12201

NCT ID:

NCT05524051

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery

What is this study about?

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Who Cannot Join the Study?