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Tin816

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.

Table of Contents

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[1]. 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[1].

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[1].
  • Duration: The study will last up to 120 days, with a screening period of up to 30 days[1].
  • Number of participants: Approximately 120 subjects will be involved in the study[1].
  • Evaluation period: The main efficacy evaluation will be done 5 days after treatment[1].

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[1].

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[1].

Secondary Outcomes

In addition to the main goal, the study will also look at several other important factors:

  1. 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[1].
  2. Immunogenicity: The study will check if patients develop antibodies against TIN816, which could affect how well the drug works or potentially cause side effects[1].
  3. 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[1].

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[1].

Aspect Details
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

FAQ

  • What is the purpose of the TIN816 clinical trial? The trial aims to evaluate the safety, tolerability, and effectiveness of TIN816 in preventing acute kidney injury in adult patients undergoing cardiac surgery who are at high risk for this complication.
  • How long does the study last? The entire study lasts up to 120 days, with a screening period of up to 30 days before the surgery and treatment.
  • How many participants are involved in the trial? Approximately 120 subjects will be involved in the trial, randomly assigned to receive either TIN816 or a placebo.
  • What is the main way the researchers will measure the effectiveness of TIN816? The primary measure of effectiveness is the ratio of the highest serum creatinine value (a marker of kidney function) up to and including Study Day 6 compared to the baseline value before surgery.
  • Will the study look at long-term effects of TIN816? Yes, the study will assess long-term effects by looking at major adverse kidney events at 30 and 90 days after surgery, which helps evaluate the drug's impact on acute kidney disease.

Ongoing Clinical Trials on Tin816

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

    Not recruiting

    2 1
    Investigated drugs:
    Belgium Czechia Estonia France Germany Hungary +1

  • Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +2

Glossary

  • Acute Kidney Injury (AKI): A sudden decrease in kidney function that can occur after major surgery, particularly cardiac procedures. It can lead to serious complications and is what TIN816 aims to prevent.
  • Serum Creatinine: A waste product in the blood that is normally filtered out by the kidneys. Higher levels can indicate reduced kidney function and is used as a marker to assess kidney health in this study.
  • Placebo: A substance with no active medical effects, used as a control in the study to compare with the actual drug (TIN816) to determine its effectiveness.
  • Randomized Trial: A type of study where participants are randomly assigned to different treatment groups (in this case, TIN816 or placebo) to reduce bias in the results.
  • Blinded Study: A study design where participants and investigators do not know who is receiving the actual drug or the placebo, helping to prevent bias in the results.
  • MAKE (Major Adverse Kidney Event): A measure used in the study to assess long-term kidney health outcomes, looking at events at 30 and 90 days after surgery.
  • Anti-drug Antibodies: Proteins produced by the immune system in response to a drug. The study will check for these to assess if the body develops an immune response to TIN816.
  • Immunogenicity: The ability of a substance, like TIN816, to provoke an immune response in the body. This is being assessed as part of the drug's safety profile.

References