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

Recruiting

• Conditions: FSGS; MCD; Focal Segmental Glomerulosclerosis; Minimal Change Disease
• Interventions: Other: Biospecimen collection; Other: Data collection

• Registration Number: NCT05650619
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study Start: 2022-12-08
• Study First Posted: 2022-12-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled participant after transplant	Data collection	Participants will be consented.
Enrolled participants prior to transplant	Biospecimen collection	Participants will be consented.
Enrolled participant after transplant	Biospecimen collection	Participants will be consented.
Retrospective participant data	Data collection	Waiver of consent for secondary use of existing data.
Enrolled participants prior to transplant	Data collection	Participants will be consented.

Primary Outcome Measures

Name	Time	Method
Time to FSGS Recurrence	2 years after transplant
Time to Graft Failure	2 years after transplant

Secondary Outcome Measures

Name	Time	Method
Proportion with acute rejection	2 years after transplant
Define the Endophenotypes in each group of recurrent FSGS and MCD	2 years after transplant	Classifications for the dataset using non-hierarchical clustering techniques
Proportion with delayed graft function	2 years after transplant
Proportion of recurrence and time to graft failure	2 years after transplant
Proteinuria change over time	Baseline (at transplant), 2 years

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States