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

ConditionsFocal Segmental GlomerulosclerosisMinimal Change DiseaseFSGSMCD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Pathologic diagnosis other than FSGS or MCD

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Biospecimen collection

    Other intervention

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

  • Data collection

    Other intervention

    Data collection for all groups

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Enrolled participants prior to transplant2 interventions
Group B: Enrolled participant after transplant2 interventions
Group C: Retrospective participant data1 intervention

Trial outcomes

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

Classifications for the dataset using non-hierarchical clustering techniques

Time frame
2 years after transplant
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
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