CDSCO Panel approves Novartis Protocol Amendment Proposal For TIN816 study in Sepsis-associated Acute Kidney Injury
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-05 12:00 GMT | Update On 2025-01-05 12:00 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by Novartis for the renal drug TIN816 study.
This came after the firm presented protocol amendment version 01 dated 17 Apr 2024 and protocol amendment version 02 dated 29 Apr 2024, protocol no. CTIN816B12202. This is a multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)".
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