TIN816 for Acute Kidney Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TIN816 to determine its safety and effectiveness for people at risk of kidney damage after heart surgery. The study compares TIN816 to a placebo (an inactive substance) to assess its effectiveness. Suitable candidates for this trial have stable vital signs and plan to undergo a specific type of heart surgery with a long operation time. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for the TIN816 trial?
The trial protocol does not specify if you need to stop taking your current medications. However, your pulse rate should be stable with or without medication, and you cannot use other investigational drugs close to the time of enrollment.
Is there any evidence suggesting that TIN816 is likely to be safe for humans?
Research has shown that TIN816 has been tested for safety in patients with sudden kidney problems caused by sepsis. In these studies, TIN816 was generally well-tolerated, with most patients not experiencing serious side effects. Some individuals did encounter mild side effects, but these were not severe. Since this trial is in Phase 2, earlier studies have already demonstrated some level of safety. This suggests that doctors consider it safe enough for more people to try. However, new side effects could still emerge as more people use it.12345
Why do researchers think this study treatment might be promising for acute kidney injury?
Unlike standard treatments for acute kidney injury, which often focus on managing symptoms or supporting kidney function, TIN816 offers a novel approach by potentially targeting the underlying causes of the injury. Researchers are excited about TIN816 because it might work by a new mechanism that directly addresses kidney damage at a cellular level, offering a more direct method of treatment. This could mean improved outcomes and faster recovery times for patients compared to existing therapies.
What evidence suggests that TIN816 might be an effective treatment for acute kidney injury?
Research has shown that TIN816, which participants in this trial may receive, might help treat sudden kidney problems, known as acute kidney injury (AKI). Studies on patients with AKI caused by sepsis, a severe infection, found that TIN816 improved kidney function. These studies tested various treatment doses and observed encouraging results. While the research primarily focused on AKI from sepsis, it also suggests that TIN816 could benefit those at risk of AKI after heart surgery. Overall, these early findings indicate that TIN816 could be a useful treatment for kidney injuries.12567
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticasl
Are You a Good Fit for This Trial?
Adults over 45 years old at risk of kidney injury after non-emergency heart surgery can join. They must be able to understand the study, weigh between 50-150 kg with a BMI under 40, and have stable vital signs. They cannot have had a recent significant increase in creatinine levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TIN816 or placebo following cardiac surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- TIN816
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD