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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)
- ClinicalTrials.gov ID
- NCT05650619
- Acronym / sponsor ID
- RESOLVE / HUM00221259
- Conditions
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, FSGS, MCD
- Keywords
- Kidney disease, Kidney transplant, Adult, Children, Recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enrolled participants prior to transplant | – | Other: Biospecimen collection, Other: Data collectionParticipants will be consented. |
| Enrolled participant after transplant | – | Other: Biospecimen collection, Other: Data collectionParticipants will be consented. |
| Retrospective participant data | – | Other: Data collectionWaiver of consent for secondary use of existing data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Pathologic diagnosis other than FSGS or MCD
- FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collectionSpecimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank. | Other | Enrolled participant after transplant, Enrolled participants prior to transplant |
| Data collectionData collection for all groups | Other | Enrolled participant after transplant, Enrolled participants prior to transplant, Retrospective participant data |
Primary outcome
Time to FSGS Recurrence
Time frame: 2 years after transplant
Time to Graft Failure
Time frame: 2 years after transplant
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eloise Salmon, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Rahimi (734-647-5446, asboggs@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to FSGS Recurrence (time frame: 2 years after transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.