New Delhi: The Subject Expert Committee (SEC) under the Central Drug Standard Control Organization (CDSCO) has given its approval for the protocol amendment proposal by Novartis for the TIN816 study. This study focuses on the renal drug TIN816, which is being investigated for its potential in treating sepsis-associated acute kidney injury (SA-AKI).
The approval follows the presentation of two protocol amendments by Novartis: version 01 dated 17 Apr 2024 and version 02 dated 29 Apr 2024, under protocol no. CTIN816B12202. The study is described as a multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study. It aims to evaluate the safety and efficacy of TIN816 administered through a single intravenous infusion in participants with SA-AKI.
TIN816 is a novel drug under development for the treatment of SA-AKI and acute kidney injury following cardiac surgery. It is administered intravenously and works by targeting adenosine triphosphatase (ATP). Acute kidney injury represents a sudden decrease in kidney function, a condition that can lead to serious complications, especially after major surgeries like heart surgery.
At the SEC meeting held on 17th December 2024, the committee reviewed the presented protocol amendments and, after thorough deliberation, recommended their approval. This marks a significant step forward in the development of TIN816 as a potential treatment for patients at risk of acute kidney injury post-cardiac surgery.
