KHI Current Project
Clinical Trials in Pediatric Patients with IgA Nephropathy (IgAN)
Community Unmet Need
In recent years, there has been a dramatic increase in drug development for IgAN; however, clinical trials are largely being conducted in adults. At this time, it is not clear whether the efficacy and safety of these treatments should also be assessed in children with IgAN, and, if so, how best to design studies to obtain the data needed to support use of novel therapies in this population.
Project Approach
The project team will approach this project by engaging subject matter experts to assess the current literature and trial landscape to formulate a community consensus on a path forward for developing therapies for children with IgA Nephropathy. Additionally, the project team will engage stakeholders who have clinical trial or registry data that can be used to inform natural history of disease research, or identify biomarkers candidates and outcome measurements that advance therapies for children living with IgA Nephropathy. This data would then be shared to a central repository for analysis in potential partnership of organizations such as the Critical Path Institute. This project is divided into two phases:
- Develop a harmonized data set for pediatrics with IgA Nephropathy
- Publish a report of findings of data accumulation/analysis from shared registry and trial data and suggest a path forward for developing therapies for children with IgA Nephropathy.
Deliverables
- Harmonized dataset for pediatrics with IgA Nephropathy
- Manuscript