Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease (RESOLVE)

University of Michigan

Status: Enrolling

Conditions: Minimal Change Disease; FSGS; MCD; Focal Segmental Glomerulosclerosis

Treatments: Other: Data collection; Other: Biospecimen collection

Study type: Observational

Funder types: Other

Identifiers

NCT05650619

HUM00221259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 3 patient groups

Enrolled participants prior to transplant

Description:

Participants will be consented.

Treatment:

Other: Biospecimen collection

Other: Data collection

Enrolled participant after transplant

Description:

Participants will be consented.

Treatment:

Other: Biospecimen collection

Other: Data collection

Retrospective participant data

Description:

Waiver of consent for secondary use of existing data.

Treatment:

Other: Data collection