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Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

NCT05507437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-04

Study results available
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Summary

The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

Conditions

  • Acute Kidney Injury Due to Sepsis

Interventions

BIOLOGICAL

TIN816 70 mg lyophilisate powder

Recombinant human CD39 enzyme

OTHER

Placebo

0.9% sterile sodium chloride solution

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2024-04-25
Completion
2024-04-25

Countries

  • Belgium
  • France
  • Germany
  • Hungary
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05507437 on ClinicalTrials.gov