BridgeMD
A multi-center study to evaluate the safety, tolerability and efficacy of TIN816 in patients at risk for acute kidney injury following a cardiac surgery.
EU CTIS ID: 2024-511621-64-00
What this study is testing
To assess the effect of TIN816 on serum creatinine levels in patients at high risk for AKI and undergoing major cardio-vascular surgery, versus placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study. Article I. Participants must be able to communicate well with the investigator and to understand and comply with the requirements of the study. Article II. Male and female patients ≥45 years at screening Article III. Participants must weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below 40. BMI = Body weight (kg) /[Height (m)]2
- At screening, vital signs should be assessed in the sitting or supine position and be within the following ranges: a. body temperature between 35.0-37.5 °C b. blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg) c. pulse rate (50-100/min) stable with or without medication(s) as per Investigator‘s assessment. If vital signs are outside these ranges, the Investigator may obtain two additional readings, so that up to three consecutive assessments are made. At least the last reading must be within the ranges provided above for the participant to qualify.
- Stable renal function with no known increase in SCr of ≥25% at screening visit compared to a previous value obtained within the last 6 months as documented by a local laboratory using standard assay methodology, and no AKI present (any stage) at pre-surgery baseline at discretion of the investigator.
- Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with expected CPB time ≥1 hour
You likely can't join if
- eGFR at screening <15 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation)
- Receiving renal replacement therapy (RRT) currently or at any time within 3 months prior to screening, or scheduled to start RRT shortly after cardiac surgery.
- Patients with bleeding risk at screening, or identified as such pre-surgery if screening was performed earlier than Day -1. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following: • History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator • Thrombocytopenia: platelet count <100x109/L • History of platelet dysfunction e.g., ADP induced platelet aggregation lower than 60% • History of coagulation factor deficiencies, including but not limited to fibrinogen ≤ 2.5 g/L or Von Willebrand factor (vWF) ≤ 50 IU/dL.
- Duration of cardiopulmonary bypass (CPB) <60 minutes
- Patient with active bleeding at the end of the surgery as per assessment of the leading surgeon
- Donation or loss of >450 mL of blood or > 200 mL of plasma within four weeks prior to dosing, or longer if required by local regulation
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study. Article I. Participants must be able to communicate well with the investigator and to understand and comply with the requirements of the study. Article II. Male and female patients ≥45 years at screening Article III. Participants must weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below 40. BMI = Body weight (kg) /[Height (m)]2
- At screening, vital signs should be assessed in the sitting or supine position and be within the following ranges: a. body temperature between 35.0-37.5 °C b. blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg) c. pulse rate (50-100/min) stable with or without medication(s) as per Investigator‘s assessment. If vital signs are outside these ranges, the Investigator may obtain two additional readings, so that up to three consecutive assessments are made. At least the last reading must be within the ranges provided above for the participant to qualify.
- Stable renal function with no known increase in SCr of ≥25% at screening visit compared to a previous value obtained within the last 6 months as documented by a local laboratory using standard assay methodology, and no AKI present (any stage) at pre-surgery baseline at discretion of the investigator.
- Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with expected CPB time ≥1 hour
What rules you out
- eGFR at screening <15 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation)
- Receiving renal replacement therapy (RRT) currently or at any time within 3 months prior to screening, or scheduled to start RRT shortly after cardiac surgery.
- Patients with bleeding risk at screening, or identified as such pre-surgery if screening was performed earlier than Day -1. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following: • History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator • Thrombocytopenia: platelet count <100x109/L • History of platelet dysfunction e.g., ADP induced platelet aggregation lower than 60% • History of coagulation factor deficiencies, including but not limited to fibrinogen ≤ 2.5 g/L or Von Willebrand factor (vWF) ≤ 50 IU/dL.
- Duration of cardiopulmonary bypass (CPB) <60 minutes
- Patient with active bleeding at the end of the surgery as per assessment of the leading surgeon
- Donation or loss of >450 mL of blood or > 200 mL of plasma within four weeks prior to dosing, or longer if required by local regulation
- Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest or scheduled to undergo TAVI or TAVR only or single vessel, minimally invasive direct coronary artery bypass (MIDCAB) off-pump surgeries or left ventricular assist device (LVAD) implantation.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- India
- Taiwan
- Argentina
- Canada
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; India; Taiwan; Argentina; Canada; Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.