Trial intelligence / Profile preview

CLEAR-AKI: TIN816 in Sepsis-associated Acute Kidney Injury

NCT05996835Phase 2

Key facts

Status: Completed
Start: Jan 2024
Primary completion: Feb 2026
Countries: 17
Sponsor: Novartis
Modality: Recombinant Proteins and Enzymes

Drugs: TIN-816
Conditions: sepsis-associated acute kidney injury (S-AKI)

Overview

Phase 2, randomised, double-blind trial of TIN-816 in sepsis-associated acute kidney injury (S-AKI) (4 arms), sponsored by Novartis. Primary endpoint: Average of area under the time-corrected creatinine clearance curve (AUC1-8). Started Jan 2024; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

TIN816 Dose A
Single intravenous infusion of TIN816 Dose A.
TIN816 Dose B
Single intravenous infusion of TIN816 Dose B.
TIN816 Dose C
Single intravenous infusion of TIN816 Dose C.
Placebo
Single intravenous infusion of 0.9% sterile saline.

Who it enrols

Adults aged 18-85 admitted to ICU/HDU with sepsis and acute kidney injury (AKI Stage 1 or greater). Excludes patients with severe pre-existing chronic kidney disease, those receiving or about to receive renal replacement therapy, and those with active hepatitis B/C, advanced liver disease, or active hematological malignancies.

Endpoints

Primary

Average of area under the time-corrected creatinine clearance curve (AUC1-8)Day 1 to Day 8

Secondary

Percentage of participants with major adverse kidney events (MAKE)Day 1 to Day 90
Area under the time-corrected endogenous serum creatinine curveDay 1 to Day 30
Area under the time-corrected endogenous serum cystatin C curveDay 1 to Day 30
Area under the time-corrected creatinine clearance curve (AUC5-14)Day 5 to Day 14
Percentage of participants who had renal replacement therapy (RRT)Day 1 to Day 90
Percentage of participants with RRT dependencyDay 90
Number of days participants alive and free of RRTDay 1 to Day 90
Change in Kidney disease improving global outcomes (KDIGO) scoreDay 14

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