Abstract: TH-PO003
Advancing Treatments for CKD: Trends and Opportunities
Session Information
- Educational Research
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Educational Research
- 900 Educational Research
Authors
- Bevan, Andrew M., Evidera, a business of PPD, part of Thermo Fisher Scientific, London, United Kingdom
- Garrisi, Davide, PPD, part of Thermo Fisher Scientific, Morrisville, North Carolina, United States
- Angeles, Carmichael, PPD, part of Thermo Fisher Scientific, Morrisville, North Carolina, United States
Background
Several factors, including high unmet need, ongoing evolution of endpoints and faster approval tracks make nephrology an interesting development opportunity, which has contributed to a renewed interest in clinical development. We undertook an analysis of metadata from Clinicaltrials.gov (CT.gov) to characterize trends over the last 20 years and what this may tell us about the future trajectory for treatment development.
Methods
CT.gov was searched for studies of drugs or biologicals containing the terms "Chronic Renal Failure", "Chronic Renal Disease", "Chronic Kidney Disease" or "Chronic Renal Insufficiency" posted from 01-Jan-2002 and 31-Dec-2021. 1038 records were returned and 194 were excluded due the study intervention being either behavioral, procedural, diagnostic, dietary supplement or “other”. 844 studies in the analysis were divided into 2 time periods: P1 - 2002 to 2011, and P2 - 2012 to 2021, and analyzed by study phase, population type, type of intervention and funding.
Results
There was a 54% increase studies in P2 vs P1 with the most marked increase in early phase studies, which increased by 132%. Most studies were in adults (P1 88%, P2 91%). The number of industry funded studies increased by 32% in P2 vs P1; however, the increase was a more marked in non-industry funded studies, which doubled. In terms of intervention type, there was a 19-fold increase in the number of studies investigating biological interventions in P2 (39) vs P1 (2). Hemoglobin (Hb) was the most frequently assessed primary endpoint in industry sponsored studies, increasing by 55% in P2 vs P1.
Conclusion
Our data provides evidence of increased clinical research activity in CKD in the last 10 years and more focus on biologicals that are best designed to precisely target complex biological pathways in disease pathophysiology. Targeted therapies have the potential to transform the treatment of CKD in children, where the level of unmet medical need is high. However, our results did not reveal an increase in research activity in pediatrics. The marked growth in studies investigating the effect of therapies on Hb reflects the surge in interest in the study of CKD-anemia. The marked rise in non-industry funded studies may indicate a growth in basic science that may translate into further increases in industry sponsored research in the future.
Funding
- Commercial Support –