Abstract: SA-PO0647
The IgAN Revolution and the Unmet Needs in Pediatric Patients
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - Other
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Garrisi, Davide, Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States
- Stump, Sarah Dixon, Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States
- Angeles, Carmichael, Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States
- Baer, Gerri, Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States
- Troutman, Hannah R., Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States
Background
Clinical development in IgA nephropathy has been a major contributor of the “golden age” of nephrology. New drugs with diverse mechanisms of action were approved, others are in clinical development, and all these are expected to provide nephrologists and patients with new and alternative therapeutic options towards a much more personalized approach. However, we are not aware of any publication to date that quantified the magnitude of IgA nephropathy clinical development, analysing differences in the number of clinical trials by year, industry-sponsored vs academic research, and trends between adult and pediatric trials.
Methods
Clinical trials in IgAN registered on ClinicalTrials.gov between January 1, 2006, and December 31, 2025, were identified. Studies were grouped into two periods: Period 1 (P1, 2006–2015) and Period 2 (P2, 2016–2025). Trials were analyzed by phase, funding source (industry vs non-industry), and population (adult vs pediatric). Comparisons used two-tailed t-tests with unequal variances.
Results
A total of 130 trials met inclusion criteria: 36 in P1 and 94 in P2, showing a significant increase in P2 (p = 0.013). This growth was driven by industry-sponsored studies, which rose from 10 to 61 (p = 0.007), a six-fold increase. Non-industry studies increased modestly (26 to 33).
Adult trials increased significantly from 27 in P1 to 87 in P2 (p = 0.006). In contrast, pediatric trials decreased slightly from 9 to 7.
Conclusion
Clinical trials in IgA nephropathy registered in ClinicalTrials.gov in the last 20 years, divided into two periods, Period 1 (P1, 2006-2015) and Period 2 (P2, 2016-2025), showed a statistically significant increase in number of studies between P2 and P1. This increase was dominated by industry-sponsored studies in adult patients. There was no increase, but a reduction in of studies in pediatric patients. Our findings indicate that while the number of clinical studies in IgA nephropathy substantially increased in P2 compared to P1, this was limited to studies in adult population. Studies in the pediatric population are still very limited and not yet addressing a high unmet need.
Funding
- Commercial Support – Thermo Fisher Scientific