In short
A new clinical trial is underway to investigate the potential of TIN816, a drug designed to protect patients from acute kidney injury following cardiac surgery. This study aims to assess the safety, tolerability, and effectiveness of TIN816 compared to a placebo in adult patients who are at high risk for kidney complications after major heart surgery. The trial involves multiple medical centers and will provide valuable insights into how TIN816 may help preserve kidney function in vulnerable patients undergoing cardiac procedures.
At a glance
- Study Type
- Randomized, multi-center, placebo-controlled, blinded
- Drug Tested
- TIN816
- Target Condition
- Acute Kidney Injury Following Cardiac Surgery
- Number of Participants
- Approximately 120
- Study Duration
- Up to 120 days
- Primary Outcome Measure
- Ratio of highest serum creatinine value to baseline
- Secondary Outcomes
- AKI stages, immunogenicity, major adverse kidney events
- Long-term Follow-up
- 30 and 90 days post-surgery
What is TIN816?
TIN816 is a new drug that is currently being studied for its potential to help patients who are at risk of developing acute kidney injury (AKI) after undergoing cardiac surgery. While we don't have detailed information about its chemical structure or mechanism of action, we know that it's being tested in clinical trials to see if it can protect the kidneys from damage during and after heart surgery.
Target Condition: Acute Kidney Injury Following Cardiac Surgery
Acute kidney injury is a sudden decrease in kidney function that can occur after major surgeries, especially heart surgeries. This condition can be serious and may lead to complications or even long-term kidney problems. TIN816 is being developed specifically to address this risk in patients undergoing cardiac surgery.
Clinical Trial Details
A clinical trial is currently underway to evaluate TIN816. Here are some key details about the study:
- Type of study: This is a randomized, multi-center, placebo-controlled, and blinded study. This means that participants are randomly assigned to receive either TIN816 or a placebo, and neither the participants nor the researchers know who is receiving which treatment during the study.
- Duration: The study will last up to 120 days, with a screening period of up to 30 days.
- Number of participants: Approximately 120 subjects will be involved in the study.
- Evaluation period: The main efficacy evaluation will be done 5 days after treatment.
Primary Outcome: Effect on Serum Creatinine
The main goal of the study is to assess how TIN816 affects serum creatinine levels in high-risk patients undergoing major cardiovascular surgery, compared to a placebo. Serum creatinine is a waste product in your blood that's normally filtered out by your kidneys. Higher levels can indicate that your kidneys aren't functioning properly.
Specifically, the researchers will look at the ratio of the highest serum creatinine value up to and including Study Day 6 versus the baseline (starting) value. This will help them understand if TIN816 is effective in preventing or reducing kidney damage.
Secondary Outcomes
In addition to the main goal, the study will also look at several other important factors:
- AKI stages: The researchers will assess how TIN816 affects the incidence and severity of acute kidney injury, using a classification system called the AKI Network criteria.
- Immunogenicity: The study will check if patients develop antibodies against TIN816, which could affect how well the drug works or potentially cause side effects.
- Long-term kidney events: The researchers will look at the occurrence of major adverse kidney events at 30 and 90 days after surgery (called MAKE30 and MAKE90). This helps understand the longer-term effects of TIN816 on kidney health.
Safety and Tolerability
An important aspect of this study is to evaluate the safety and tolerability of TIN816. While specific safety measures aren't detailed in the provided information, it's standard practice in clinical trials to closely monitor participants for any side effects or adverse reactions. This information will be crucial in determining whether TIN816 is safe for wider use in patients undergoing cardiac surgery.