CTIN816B12202: Sepsis-Associated Acute Kidney Injury study
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)
IRAS ID
1007076
Contact name
Daniel Monney
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
Sepsis is a potentially life-threatening reaction to an infection. It occurs when the immune system overreacts to an infection and starts to damage tissues and organs in the body. One organ which can be particularly affected by sepsis is the kidney.
The kidneys play a crucial role in filtering waste products and maintaining the body's fluid balance. When sepsis occurs, the infection and the body's immune response can disrupt the normal functioning of the kidneys, leading to sepsis-associated acute kidney injury (SA-AKI). As a result, patients admitted to the hospital with sepsis are often admitted to the intensive care unit (ICU) and may require kidney dialysis – a treatment for kidney failure that rids the body of unwanted toxins, waste products and excess fluids by filtering the blood.
Given the high risk of death or longer-term kidney damage associated with SA-AKI and the limited treatment options available, there is a compelling rationale for targeting research in this condition to develop new treatments.
A human enzyme (a type of protein) made in a laboratory called TIN816 has been developed by Novartis which is given to participants via intravenous (IV) infusion i.e., through a vein. TIN816 targets a key component of the body's response to sepsis reducing levels of inflammation and blood clots in the kidney and other organs in the body. This should improve the function of the kidney and improve recovery from SA-AKI.
The purpose of this study is to find out whether different doses of TIN816 can improve kidney function compared to placebo (something that looks like TIN816 but has no active ingredients) and whether TIN816 is safe and has any side-effects.
Approximately 320 adult patients between the ages of 18 and 85 years old with SA-AKI are being invited to join this study. The study will take place in approximately 21 countries, with around 4-5 sites in the UK. Participants will be in the study for ~90 days.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0374
Date of REC Opinion
7 Dec 2023
REC opinion
Further Information Favourable Opinion