The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes. The purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.
RESOLVE is a multicenter, observational cohort study to examine the post-transplant course of patients with FSGS and MCD across the lifespan. The study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. With multiple enrollment options, the study will allow investigators to define the incidence and prevalence of FSGS recurrence, describe the post-transplant course of patients with FSGS and MCD across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.
Study Type
OBSERVATIONAL
Enrollment
300
Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
Data collection for all groups
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGTime to FSGS Recurrence
Time frame: 2 years after transplant
Time to Graft Failure
Time frame: 2 years after transplant
Define the Endophenotypes in each group of recurrent FSGS and MCD
Classifications for the dataset using non-hierarchical clustering techniques
Time frame: 2 years after transplant
Proportion of recurrence and time to graft failure
Time frame: 2 years after transplant
Proportion with acute rejection
Time frame: 2 years after transplant
Proteinuria change over time
Time frame: Baseline (at transplant), 2 years
Proportion with delayed graft function
Time frame: 2 years after transplant
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