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Recruiting NCT05650619

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

— Observational Focal Segmental Glomerulosclerosis Minimal Change Disease FSGS MCD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen collection, Data collection.
Who it may be relevant to
Registry conditions: Focal Segmental Glomerulosclerosis, Minimal Change Disease, FSGS, MCD. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Time to FSGS Recurrence [Time frame: 2 years after transplant]
  • Time to Graft Failure [Time frame: 2 years after transplant]
Secondary outcome measures (5)
  • Define the Endophenotypes in each group of recurrent FSGS and MCD [Time frame: 2 years after transplant]
  • Proportion of recurrence and time to graft failure [Time frame: 2 years after transplant]
  • Proportion with acute rejection [Time frame: 2 years after transplant]
  • Proteinuria change over time [Time frame: Baseline (at transplant), 2 years]
  • Proportion with delayed graft function [Time frame: 2 years after transplant]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT05650619 · HUM00221259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗