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NCT Number: NCT05650619

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

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.

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Key information

Conditions

Focal Segmental Glomerulosclerosis Disease Attributes FSGS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulosclerosis, Focal Segmental Kidney Diseases MCD Macular dystrophy, corneal type 1 Male Urogenital Diseases Minimal Change Disease Nephritis Nephrosis Nephrosis, Lipoid Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Debbie Gipson, MD

SUB_INVESTIGATOR

Eloise Salmon, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

734-232-4830

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biospecimen Collection

Other

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

Data Collection

Other

Data collection for all groups

Primary outcomes

  1. Time to FSGS Recurrence

    Time frame: 2 years after transplant

  2. Time to Graft Failure

    Time frame: 2 years after transplant

Secondary outcomes

  1. Define the Endophenotypes in each group of recurrent FSGS and MCD

    Time frame: 2 years after transplant

    Classifications for the dataset using non-hierarchical clustering techniques

  2. Proportion of recurrence and time to graft failure

    Time frame: 2 years after transplant

  3. Proportion with acute rejection

    Time frame: 2 years after transplant

  4. Proteinuria change over time

    Time frame: Baseline (at transplant), 2 years

  5. Proportion with delayed graft function

    Time frame: 2 years after transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Rahimi

CONTACT

[email protected]

734-647-5446

Eloise Salmon, MD

CONTACT

[email protected]

734-936-4210

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: RESOLVE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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