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A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

NCT05524051 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-02

Study results available
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Summary

This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

Conditions

  • Acute Kidney Injury Following Cardiac Surgery

Interventions

DRUG

TIN816

TIN816 was administered as a single intravenous (i.v.) infusion over 2 hours.

OTHER

Placebo

Placebo was administered as a single intravenous (i.v.) infusion over 2 hours.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticasl

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2025-03-26
Completion
2025-06-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Lithuania
  • Singapore
  • Spain
  • Taiwan

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 NCT05524051 on ClinicalTrials.gov