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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen collection | Other | Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to FSGS Recurrence | 2 years after transplant | |
| Time to Graft Failure | 2 years after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Define the Endophenotypes in each group of recurrent FSGS and MCD | Classifications for the dataset using non-hierarchical clustering techniques | 2 years after transplant |
| Proportion of recurrence and time to graft failure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Rahimi | Contact | 734-647-5446 | asboggs@med.umich.edu | |
| Eloise Salmon, MD | Contact | 734-936-4210 | salmonel@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eloise Salmon, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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Optional: DNA bio-specimens blood or saliva.
| Data collection | Other | Data collection for all groups |
|
| 2 years after transplant |
| Proportion with acute rejection | 2 years after transplant |
| Proteinuria change over time | Baseline (at transplant), 2 years |
| Proportion with delayed graft function | 2 years after transplant |
| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| D009402 | Nephrosis, Lipoid |
| C537834 | Macular dystrophy, corneal type 1 |
| D007674 | Kidney Diseases |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009401 | Nephrosis |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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