Submit Revise Protocol for TIN-816 : CDSCO panel Tells Novartis
New Delhi: In response to the proposal to conduct the Phase IIa clinical trial of TIN-816 presented by the drug major Novartis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm revise the protocol of TIN-816.
This came after the drug major Novartis presented the proposal for a grant of permission to conduct a Phase IIa clinical trial of TIN-816 before the committee.
TIN-816 is under development for the treatment of sepsis-associated acute kidney injury (SA-AKI) and acute kidney injury following cardiac surgery. It is administered through an intravenous route in the form of powder.
At the recent SEC meeting of Cardiovascular and Renal held on 6th and 7th July 2023, the expert panel reviewed the proposal for the grant of permission to conduct the Phase IIa clinical trial of the TIN-816.
After detailed deliberation, the committee recommended that the firm should submit a revised protocol considering the following:
1. Considering all the inclusion criteria, the only criteria for “at risk for AKI” following cardiac surgery is renal dysfunction defined at point no. 7 as GFR < 60 ml/min with different values for three different age groups. GFR < 60 ml/min can be either AKI or AKD or CKD. There is no other 4th category. Therefore, the firm should clarify the point no. 7 in the inclusion criteria is related to which of the three groups.
2. Point No. 6 in the inclusion criteria should be part of the exclusion criteria.
3. Amendment in point no. 6 of inclusion criteria “(ideally obtained at least 3 weeks before the screening visit) is not appropriate.
Accordingly, the expert panel stated that the revised protocol should be submitted for review by the committee.
