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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05650619
Acronym
RESOLVE
Enrollment
300
Registered
2022-12-14
Start date
2022-12-08
Completion date
2027-12-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis, FSGS, MCD, Minimal Change Disease

Keywords

Kidney disease, Kidney transplant, Adult, Children, Recurrence

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.

Interventions

OTHERBiospecimen collection

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

OTHERData collection

Data collection for all groups

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Time to FSGS Recurrence2 years after transplant
Time to Graft Failure2 years after transplant

Secondary

MeasureTime frameDescription
Define the Endophenotypes in each group of recurrent FSGS and MCD2 years after transplantClassifications for the dataset using non-hierarchical clustering techniques
Proportion of recurrence and time to graft failure2 years after transplant
Proportion with acute rejection2 years after transplant
Proteinuria change over timeBaseline (at transplant), 2 years
Proportion with delayed graft function2 years after transplant

Countries

United States

Contacts

CONTACTAshley Rahimi
asboggs@med.umich.edu734-647-5446
CONTACTEloise Salmon, MD
salmonel@med.umich.edu734-936-4210
PRINCIPAL_INVESTIGATOREloise Salmon, MD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026