Clinical trial NCT05650619: Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease
Official title: Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focal Segmental Glomerulosclerosis
Minimal Change Disease
FSGS
MCD
Keywords: Kidney disease
Kidney transplant
Adult
Children
Recurrence
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include up to 10,000 subjects across three cohorts. Based on scoping data approximately 250 cases will be available from University of Michigan and approximately 100-350 from each additional participating site.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Retrospective non-consented participant group had a transplant from the year 2000 and onward.
* Diagnosis of FSGS or MCD in the native kidney (prior to transplant).

Exclusion Criteria:

* Pathologic diagnosis other than FSGS or MCD
* FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)

Primary outcomes:
measure: Time to FSGS Recurrence
timeFrame: 2 years after transplant
measure: Time to Graft Failure
timeFrame: 2 years after transplant
Secondary outcomes:
measure: Define the Endophenotypes in each group of recurrent FSGS and MCD
timeFrame: 2 years after transplant
measure: Proportion of recurrence and time to graft failure
timeFrame: 2 years after transplant
measure: Proportion with acute rejection
timeFrame: 2 years after transplant
measure: Proteinuria change over time
timeFrame: Baseline (at transplant), 2 years
measure: Proportion with delayed graft function
timeFrame: 2 years after transplant
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Eloise Salmon, MD
role: PRINCIPAL_INVESTIGATOR
References: