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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Focal Segmental Glomerulosclerosis; Minimal Change Disease; FSGS; MCD
• Intervention / Treatment: Other: Biospecimen collection; Other: Data collection

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Eloise Salmon, MD; Phone Number: 734-936-4210; Email: salmonel@med.umich.edu
• Study Contact Backup: Name: Ashley Rahimi; Phone Number: 734-647-5446; Email: asboggs@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Phone Number: 734-232-4830; Email: umkidneystudies@umich.edu
      • Principal Investigator: Eloise Salmon, MD
      • Sub-Investigator: Debbie Gipson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled participants prior to transplant; Participants will be consented.	Other: Biospecimen collection; Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.; Other: Data collection; Data collection for all groups
Enrolled participant after transplant; Participants will be consented.	Other: Biospecimen collection; Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.; Other: Data collection; Data collection for all groups
Retrospective participant data; Waiver of consent for secondary use of existing data.	Other: Data collection; Data collection for all groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to FSGS Recurrence	2 years after transplant
Time to Graft Failure	2 years after transplant

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Eloise Salmon, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Children; Recurrence; Adult; Kidney disease; Kidney transplant
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Glomerulonephritis; Nephritis; Nephrosis; Pathological Conditions, Signs and Symptoms; Recurrence; Kidney Diseases; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Macular dystrophy, corneal type 1; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: HUM00221259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No