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

NCT05650619 | Recruiting

• 1 other identifier: HUM00221259
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

MCD; Focal Segmental Glomerulosclerosis; Minimal Change Disease; FSGS

Keywords

Kidney disease; Kidney transplant; Adult; Children; Recurrence

Outcome Measures

Primary Outcomes (2)

• Time to FSGS Recurrence

  2 years after transplant

• Time to Graft Failure

  2 years after transplant

Secondary Outcomes (5)

• Define the Endophenotypes in each group of recurrent FSGS and MCD

  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

Study Arms (3)

Enrolled participants prior to transplant

Participants will be consented.

Other: Biospecimen collection; Other: Data collection

Enrolled participant after transplant

Participants will be consented.

Other: Biospecimen collection; Other: Data collection

Retrospective participant data

Waiver of consent for secondary use of existing data.

Other: Data collection

Interventions

Biospecimen collection OTHER

Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.

Enrolled participant after transplant; Enrolled participants prior to transplant

Data collection OTHER

Data collection for all groups

Enrolled participant after transplant; Enrolled participants prior to transplant; Retrospective participant data

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Optional: DNA bio-specimens blood or saliva.

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Macular dystrophy, corneal type 1; Kidney Diseases; Recurrence

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrosis; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eloise Salmon, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Rahimi

CONTACT

734-647-5446; asboggs@med.umich.edu

Eloise Salmon, MD

CONTACT

734-936-4210; salmonel@med.umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: December 8, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)