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NCT05524051 · ClinicalTrials.gov registry record · Phase 2
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT05524051: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT05524051 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05524051, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study 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.
Primary Outcome
The log-transformed ratio of the highest serum creatinine value up to and including Study Day 6 vs baseline was analysed by a linear model. The estimated mean and 90% confidence interval of the difference in log-transformed ratios vs baseline between each TIN816 treatment group and placebo were then back-transformed to obtain the geometric mean ratio. The geometric mean ratio (GMR) represents the ratio between TIN816 and placebo geometric mean estimates for the serum creatinine Day 6 to baseline
Interventions
- OTHER Placebo
- DRUG TIN816
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2025-06-23 |
| Phase | Phase 2 |
Why NCT05524051 stopped before completion
NCT05524051 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05524051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05524051 about?
NCT05524051 is a clinical study titled "A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.". 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.
What is the current status of trial NCT05524051?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2023-03-03. Estimated completion is 2025-06-23.
What interventions are being tested in trial NCT05524051?
The interventions under investigation include: Placebo (OTHER), TIN816 (DRUG).
Who is sponsoring clinical trial NCT05524051?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05524051's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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