RESOLVE: Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease
Study Details
Study Description
Brief Summary
After a kidney transplant, sometimes focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) return in the new kidney. This study is being done to try to understand why this happens in some people but not in others. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a multicenter (starting at University of Michigan and then adding sites), 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Enrolled participants prior to transplant Participants will be consented. |
Other: Biospecimen collection
Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
Other: Data collection
Data collection for all groups
|
| Enrolled participant after transplant Participants will be consented. |
Other: Biospecimen collection
Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.
Other: Data collection
Data collection for all groups
|
| Retrospective participant data Waiver of consent for secondary use of existing data. |
Other: Data collection
Data collection for all groups
|
Outcome Measures
Primary Outcome Measures
- Time to FSGS Recurrence [2 years after transplant]
- Time to Graft Failure [2 years after transplant]
Secondary Outcome Measures
- Define the Endophenotypes in each group of recurrent FSGS and MCD [2 years after transplant]
Classifications for the dataset using non-hierarchical clustering techniques
- Proportion of recurrence and time to graft failure [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]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Eloise Salmon, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00221259