First trial steering committe
The first Trial Steering Committee Meeting was held as a event at the ISNCON 2023 venue, ITC Royal Bengal, on December 14, 2023. The primary focus of the meeting was Protocol Development and Consensus Building. PI’s from various sites participated, both in-person and virtually, to contribute their expertise and insights. Throughout the meeting, several key questions were discussed, encompassing various aspects of the trial protocol. These discussions were thorough and collaborative, ensuring that different perspectives were captured and considered. The outcomes of these discussions led to the implementation of several important protocol adjustments, which paving the way for a more effective trial execution.
Clinical data managment
Christian Medical College,Vellore will be act as the centralized co-ordinating and clinical data management center. Clinical details to be entered in REDCap Centralized Database at each step after the Screening of Patient and also in each visit. We prioritize patient’s communication confidentiality by implementing security measures as well as guidelines. Our commitment ensures that all patient data is handled with the utmost care, maintaining privacy and trust throughout the trial.
Inlcusion Criteria
Exclusion Criteria
Biopsy cohort:
Study details and duration of follow-up
The study is a Phase 4, Multicenter randomized open-label active comparator Multi Arm Multi Stage Platform trial. Participants will be randomized 1:1 to the control arm or one of the five interventional arms. Four interventional arms will start concurrently with the control arm at baseline, and the fifth interventional arm will begin after the planned interim analysis at one year. The control arm will receive maximal labeled or tolerated ACEi/ARBs and 10mg/d of Dapagliflozin (SGLT2i)as Standard of Care.While other intervention arms will receive SoC with study medication as a part of kidney disease managment.
The total duration of the trial is 24 months, with key follow-up assessments at baseline, 12, 24 months. Participants will be closely monitored throughout the trial and during follow-up periods to assess the efficacy and safety of the interventions.
Saftey and compliance
In this clinical trial, adverse drug reactions (ADR) and serious adverse events (SAE) will be monitored continuously to ensure patient safety. A dedicated 24/7 helpline will be available for participants to report any unexpected reactions or medical issues at any time. This helpline is staffed by trial co-ordinators who will provide immediate assistance and guidance. All reported ADRs and SAEs will be promptly documented in REDCap, assessed, and escalated to the appropriate medical team for thorough evaluation. This ensures timely intervention and supports the overall safety of participants throughout the study.
