CompletedPhase 2

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

United States, Argentina, Australia316 participantsStarted 2024-01-18

Plain-language summary

The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent must be obtained in accordance with local regulations.
. ≥ 18 to ≤ 85 years of age
. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization:
. The most recent value within 3 months of the hospital admission. If not available:
. The most recent value between 3 and 12 months prior to hospital admission. If not available:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial for sepsis-related acute kidney injury has already completed — does that mean results are available, and if so, what did the TIN816 data show about kidney function recovery compared to standard care?
2The trial measured creatinine clearance over the first eight days, which tracks how well the kidneys are filtering — based on my current kidney function numbers, would that kind of improvement have been meaningful for someone in my situation?
3Since this was a Phase 2 trial, the main goal was still establishing safety and getting early signals on effectiveness — what do we actually know so far about whether TIN816 is safe, and are there any side effects that showed up that I should be aware of?
4Given that this study is completed and enrollment is closed, are there any follow-on Phase 3 trials or other investigational options for sepsis-related AKI that I might be eligible to discuss?
5How does the approach being tested in this trial — whatever TIN816 does to address kidney injury in sepsis — compare to what you would currently recommend as standard treatment for my condition?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average of area under the time-corrected creatinine clearance curve (AUC1-8)

Timeframe: Day 1 to Day 8

Trial details

NCT IDNCT05996835

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-25

View on ClinicalTrials.gov More Acute Kidney Injury Due to Sepsis trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent must be obtained in accordance with local regulations.
. ≥ 18 to ≤ 85 years of age
. Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
. Diagnosis of AKI Stage 1 or greater per the following criterion at randomization:
. The most recent value within 3 months of the hospital admission. If not available:
. The most recent value between 3 and 12 months prior to hospital admission. If not available:

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria