Focal Segmental GlomerulosclerosisRESOLVENCT05650619
Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease
An observational study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, FSGS
- What is being tested?
- Biospecimen collection and Data collection
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
734-232-4830, umkidneystudies@umich.edu
Eloise Salmon, MD
About this study
Official title: Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)
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.
Read the 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.
- Conditions
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, FSGS, MCD
- Being tested
- Biospecimen collection, Data collection
- Keywords
- Kidney disease, Kidney transplant, Adult, Children, Recurrence
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Macular dystrophy, corneal type 1, Kidney Diseases, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collectionOther
Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
Data collectionOther
Data collection for all groups
| Study group | Role | What they receive |
|---|---|---|
| Enrolled participants prior to transplant | Participants will be consented. Receives: Other: Biospecimen collection; Other: Data collection | |
| Enrolled participant after transplant | Participants will be consented. Receives: Other: Biospecimen collection; Other: Data collection | |
| Retrospective participant data | Waiver of consent for secondary use of existing data. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to FSGS Recurrence
Measured: 2 years after transplant
Time to Graft Failure
Measured: 2 years after transplant
Secondary outcomes (5)
Define the Endophenotypes in each group of recurrent FSGS and MCD
Classifications for the dataset using non-hierarchical clustering techniques
Measured: 2 years after transplant
Proportion of recurrence and time to graft failure
Measured: 2 years after transplant
Proportion with acute rejection
Measured: 2 years after transplant
Proteinuria change over time
Measured: Baseline (at transplant), 2 years
Proportion with delayed graft function
Measured: 2 years after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start8 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eloise Salmon, University of Michigan
- Investigators
- Eloise Salmon, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650619
- Sponsor's protocol ID
- HUM00221259
- Acronym
- RESOLVE
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No