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

Focal Segmental Glomerulosclerosis Clinical Trial

— RESOLVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650619
• Other study ID #: HUM00221259
• Status: Recruiting
• Start date: December 8, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Hailey Desmond
• Phone: 734-232-4830
• Email: heturner[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• FSGS
• Glomerulosclerosis, Focal Segmental
• MCD
• Minimal Change Disease
• Nephrosis, Lipoid
• Recurrence

Intervention

Other:
• Biospecimen collection
Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
• Data collection
Data collection for all groups

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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