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Sponsor decision for administrative reasons
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This is a study with 2 parts. Part 1 comprises a visit to collect biological samples necessary for the molecular characterization of chronic kidney disease. Part 2 comprises an observational period of 5 visits over a period up to 8 weeks. During Part 2, baseline tests will be conducted, and urine will be collected approximately every 2 weeks for 8 weeks. Patients may participate in Part 1, Part 2, or both, and will be followed for up to 1 year consisting of data collection from the patient's medical records and home collection of urine samples every 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSGS/TR-MCD | Patients with FSGS/TR-MCD |
| |
| Diabetic Nephropathy (DN) | Patients with DN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSGS/TR-MCD | Other | This is a non-interventional study |
| |
| Diabetic Nephropathy (DN) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine Protein-to-Creatinine Ratio (UPCR) | Approximately 1 year | |
| Change in Urine Albumin-to-Creatinine Ratio (UACR) | Approximately 1 year | |
| Estimated Glomerular Filtration Rate (eGFR) | Baseline/Biomarker collection visit | |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Approximately 8 weeks | |
| Change in Urine Biomarker: Nephrin | Approximately 1 year | |
| Change in Urine Biomarker: Podocin | Approximately 1 year | |
| Change in Urine Biomarker: Rac1 | Approximately 1 year | |
| Change in Urine Biomarker: Synaptopodin | Approximately 1 year | |
| Change in Urine Biomarker: Urea | Approximately 1 year | |
| Change in Urine Biomarker: Other Exploratory | Approximately 1 year | |
| Change in Serum/Plasma Biomarker: Other Exploratory | Approximately 8 weeks |
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Inclusion Criteria:
For FSGS/TR-MCD patients :
For DN patients:
Exclusion Criteria:
For FSGS/TR-MCD patients:
For DN patients:
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Patients will be drawn from participating investigators' clinics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventiv Research - Phoenix | Mesa | Arizona | 85210-6041 | United States | ||
| Glendale Adventist Medical Center |
Patient reported outcome (and other relevant data) will be shared with other researchers.
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whole blood, urine
| Other |
This is a non-interventional study |
|
| Number of patients with genetic variants predicted to be associated with chronic kidney disease and functional consequence | DNA analysis of blood sample | Baseline/Biomarker collection visit |
| Gene expression profile and phenotype of inducible pluripotent stem cell (iPSC)-generated organoids | Generation of iPSC from whole blood sample | Baseline/Biomarker collection visit |
| Change from Baseline Patient-reported Assessment of FSGS Symptoms | FSGS/TR-MCD patients will assess disease symptomatology utilizing the FSGS Symptom Diary and FSGS Symptom Impact Questionnaire | Approximately 8 weeks |
| Change from Baseline Patient-reported Assessment of Health Status | Patients will assess health status using the 36-Item Short Form Health Survey (SF-36) | Approximately 8 weeks |
| Change from Baseline Patient-reported Assessment of Fatigue | Patients will assess the symptom of fatigue utilizing the Modified Fatigue Impact Scale | Approximately 8 weeks |
| Change from Baseline Clinician-reported Assessment of Edema | Clinicians will assess edema in FSGS/TR-MCD patients using a standardized measurement of edema in FSGS/TR-MCD patients | Approximately 8 weeks |
| Incidence of Untoward Medical Occurrences | Incidence of untoward medical occurrences that result in death; are life threatening; require inpatient hospitalization or prolongation of existing hospitalization; result in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or result in an important medical event. | Approximately 1 year |
| % of Patients with Change in Treatment | Change in treatment as indicated by patient medical record | Approximately 1 year |
| Glendale |
| California |
| 91206 |
| United States |
| DaVita Mojave Sage Dialysis | Victorville | California | 92395-8322 | United States |
| Colorado Kidney Care | Denver | Colorado | 80230-7200 | United States |
| Renal and Transplant Associates of New England, PC | Springfield | Massachusetts | 01107-1369 | United States |
| St. Clair Nephrology | Roseville | Michigan | 48066 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404-1212 | United States |
| Clinical Research Consultants | Kansas City | Missouri | 64111 | United States |
| DaVita Pelican Point Dialysis | Las Vegas | Nevada | 89129-6201 | United States |
| High Desert Nephrology | Gallup | New Mexico | 87301-5655 | United States |
| Akron Nephrology Associates, Inc. | Akron | Ohio | 44302-1715 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404-2743 | United States |
| Arlington Nephrology, PC | Arlington | Texas | 76015 | United States |
| North Texas Kidney Disease Association | Lewisville | Texas | 75057-6039 | United States |
| South Texas Renal Care Group (Downtown) | San Antonio | Texas | 78207 | United States |
| San Antonio Kidney Disease Center Physicians Group (Wurzbach Road) | San Antonio | Texas | 78229-3809 | United States |
| South Texas Renal Care Group (Westover Hills) | San Antonio | Texas | 78251-1230 | United States |
| San Antonio Kidney Disease Center Physicians Group (Carnoustie Drive) | San Antonio | Texas | 78258-4800 | United States |
| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| D009402 | Nephrosis, Lipoid |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009401 | Nephrosis |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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