Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05650619

Conditions

Focal Segmental Glomerulosclerosis

Minimal Change Disease

FSGS

MCD

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen collection

Data collection

Study Details

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.

Conditions

Focal Segmental Glomerulosclerosis

Minimal Change Disease

FSGS

MCD

Study ID

NCT05650619

Start date

Dec 8, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled participants prior to transplant

Participants will be consented.

Enrolled participant after transplant

Participants will be consented.

Retrospective participant data

Waiver of consent for secondary use of existing data.

Interventions

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

Primary outcome measure

  • Time to FSGS Recurrence [ Time Frame: 2 years after transplant ]
  • Time to Graft Failure [ Time Frame: 2 years after transplant ]

Central Contacts and Locations

Central contacts

Ashley Rahimi

734-647-5446asboggs@med.umich.edu

Eloise Salmon, MD

734-936-4210salmonel@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

734-232-4830umkidneystudies@umich.edu

Principal Investigator:

Eloise Salmon, MD

More Information

Sponsor

University of Michigan

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Kidney disease
  • Kidney transplant
  • Adult
  • Children
  • Recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-04-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.