RESOLVE: Recurrence post-transplant observational study in Focal Segmental Glomerulosclerosis & Minimal Change Disease

Abstract

Introduction: The morbidity of recurrent focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized. Additional collaborative research is necessary to advance understanding of recurrence epidemiology, mechanisms, interventions, and outcomes, particularly in children. Methods: RESOLVE is a multicenter, observational cohort study examining the post-transplant course of patients with FSGS and MCD across the lifespan. Multiple enrollment options will facilitate both retrospective and prospective collection of biospecimens, self-report items, and electronic health record data across pediatric and adult participants. The study offers a unique mobile health option for participants to enroll and engage with the study remotely. Results: Logistic regression using a log link function will evaluate recurrence risk within 3 months of transplant based on clinical characteristics and assess the impact of social determinants of health on time to graft failure, following adjustment. Cox proportional hazards models with primary outcome of graft failure with competing risk of death will evaluate the impact of recurrence therapy and access to preventative vs reactive recurrence therapy. Independent logistic regression will evaluate the impact of recurrence therapy and endophenotypes on proteinuric outcomes. Conclusion: Multiple enrollment approaches and tailored site participation are needed while studying recurrent FSGS, due to its rarity and phenotypic variability. RESOLVE provides a framework for international collaboration to unravel the course of recurrent FSGS through a biospecimen and data repository. It also explores the potential for mobile health tools to enhance recruitment of participants and to promote cooperation among researchers to advance understanding of recurrence mechanisms and treatments.