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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as sepsis-associated acute kidney injury (SA-AKI). Sepsis is a serious condition that occurs when the body has an extreme response to an infection, which can lead to damage in various organs, including the kidneys. In this study, researchers are investigating a new treatment called TIN816, which is a powder that is mixed into a solution and given to patients through an injection or infusion into a vein. The purpose of the study is to explore how different doses of TIN816 affect kidney function in patients with SA-AKI.

Participants in the study will be randomly assigned to receive either TIN816 or a placebo, which is a solution that does not contain the active drug. The study will be conducted in a way that neither the participants nor the researchers know who is receiving TIN816 or the placebo, to ensure unbiased results. The study will last for several weeks, during which time participants will receive the treatment and have their kidney function monitored through various tests. These tests will help determine how well the kidneys are working by measuring substances like creatinine, which is a waste product filtered by the kidneys.

The study aims to gather information on the safety and effectiveness of TIN816 in improving kidney function in patients with SA-AKI. Researchers will also look at other important outcomes, such as the occurrence of any serious kidney-related events and overall health status over a period of time. The results of this study could provide valuable insights into new treatment options for patients suffering from this serious condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (18 to 85 years), admission to an intensive care or high dependency unit, and a diagnosis of sepsis with acute kidney injury (AKI).

  2. Step 2

    Randomization

    Participants are randomly assigned to one of four groups. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo.

  3. Step 3

    Treatment administration

    Participants receive either the investigational drug TIN816 or a placebo. TIN816 is administered as a powder for solution, given through an intravenous infusion. The placebo is a sterile 0.9% sodium chloride solution, also administered intravenously.

  4. Step 4

    Monitoring and assessment

    Renal function is monitored by measuring creatinine clearance from Day 1 to Day 8. Additional assessments include monitoring for major adverse kidney events, changes in kidney function, and any adverse events up to Day 90.

  5. Step 5

    Follow-up

    Participants are followed up until Day 90 to evaluate long-term outcomes, including kidney function and any ongoing need for renal replacement therapy.

Who can join the trial?

6 criteria

  • Must be between 18 and 85 years old.
  • Must be admitted to an Intensive Care Unit (ICU) or a unit that provides a high level of care.
  • Must have a diagnosis of **sepsis**. Sepsis is a serious condition that happens when the body has an extreme response to an infection. This diagnosis should be based on specific criteria, including a suspected or confirmed infection and a sudden increase in the **SOFA score** by 2 or more points. The SOFA score is a way to measure how well the body's organs are working.
  • Must have a diagnosis of **Acute Kidney Injury (AKI)** at Stage 1 or higher. AKI is a sudden decrease in kidney function. This is determined by an increase in a substance called **creatinine** in the blood by at least 0.3 mg/dL within 48 hours. Creatinine is a waste product that the kidneys usually filter out of the blood.
  • If the AKI happened in the hospital, a stable creatinine level from before the AKI diagnosis should be used as a reference.
  • If the AKI happened before coming to the hospital, the reference creatinine level should be estimated using the most recent value within 3 months before hospital admission. If not available, the most recent value between 3 and 12 months before admission should be used. If still not available, the level at hospital admission should be used.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing sepsis-associated acute kidney injury cannot participate. Sepsis is a serious condition where the body has a severe response to an infection, and acute kidney injury means the kidneys suddenly stop working properly.
  • Patients who are outside the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.
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Investigated drugs

TIN816 is an investigational medication being studied for its potential to improve kidney function in patients who have acute kidney injury associated with sepsis. The trial aims to determine how different doses of TIN816 affect kidney function, specifically by measuring creatinine clearance, which is a marker of how well the kidneys are working.

What is already known about the treatment

TIN816 – TIN816 is an investigational medication currently being studied in clinical trials for its potential to treat sepsis-associated acute kidney injury. It is administered intravenously, allowing direct delivery into the bloodstream. The medication is in the phase 2b stage of clinical trials, where its efficacy and safety are being evaluated. TIN816 is designed to improve kidney function by enhancing creatinine clearance, which is a measure of how well the kidneys are filtering waste from the blood. It falls under the pharmacological classification of renal protective agents, aiming to support kidney health in patients experiencing severe infections.

Investigated diseases

Sepsis-associated Acute Kidney Injury – This condition occurs when the kidneys suddenly stop working properly due to sepsis, a severe infection that spreads throughout the body. The kidneys, which normally filter waste from the blood, become damaged and unable to perform their function effectively. As the condition progresses, waste products and excess fluid can build up in the body, leading to further complications. The severity of kidney injury can vary, and it may develop rapidly in response to the infection. The progression of this condition can lead to a decrease in urine output and an increase in waste products in the blood. Monitoring and managing kidney function is crucial to prevent further damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505903-22-00Protocol codeCTIN816B12202Estimated enrolment339 patientsSponsorNovartis Pharma AG

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