A Study to Understand the Genetics and Clinical Course of Focal Segmental Glomerulosclerosis (FSGS), Treatment-Resistant Minimal Change Disease (TR-MCD), and Diabetic Nephropathy (DN)
NCT ID: NCT04235621
Last Updated: 2021-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
20 participants
OBSERVATIONAL
2019-12-20
2020-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FSGS/TR-MCD
Patients with FSGS/TR-MCD
FSGS/TR-MCD
This is a non-interventional study
Diabetic Nephropathy (DN)
Patients with DN
Diabetic Nephropathy (DN)
This is a non-interventional study
Interventions
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FSGS/TR-MCD
This is a non-interventional study
Diabetic Nephropathy (DN)
This is a non-interventional study
Eligibility Criteria
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Inclusion Criteria
1. Competent and willing to provide informed consent and adhere to all study assessments and restrictions.
2. Male or female ≥ 18 years of age with FSGS or TR-MCD at the time of providing written informed consent.
3. Diagnosis of FSGS or TR-MCD, based on either biopsy or genetic testing.
4. Urinary protein to creatinine ratio (UPCR) ≥ 1.0 g/g.
5. Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2.
For DN patients:
1. Competent and willing to provide informed consent and adhere to all study assessments and restrictions.
2. Male or female ≥ 18 years of age with DN at the time of providing written informed consent.
3. Diagnosis of type 2 diabetes
4. Urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g.
5. Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2.
Exclusion Criteria
1. Evidence of another kidney disease or kidney disease secondary to an infectious process.
2. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Patients whose results are compatible with prior immunization or treatment may be included.
3. Body mass index (BMI) \> 42 kg/m2.
4. Significant history or evidence of clinically significant disorder, condition, current illness, or disease that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion (eg, severe cardiac disease, cardiac conduction defect, or severe or chronic hepatobiliary disease).
5. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
6. History of any organ or bone marrow transplant, including kidney grafts.
7. History of alcoholism or drug/chemical abuse within 12 months.
8. Preplanned surgery or procedures that would interfere with the conduct of the study.
For DN patients:
1. Evidence of another kidney disease or kidney disease secondary to an infectious process.
2. History of HIV, hepatitis B, or hepatitis C. Patients whose results are compatible with prior immunization or treatment may be included.
3. BMI \> 42 kg/m2.
4. Significant history or evidence of clinically significant disorder, condition, current illness, or disease that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion (eg, severe cardiac disease, cardiac conduction defect, or severe or chronic hepatobiliary disease).
5. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
6. History of any organ or bone marrow transplant, including kidney grafts.
7. History of alcoholism or drug/chemical abuse within 12 months.
8. Preplanned surgery or procedures that would interfere with the conduct of the study.
9. Renal disease that requires immunosuppressive therapy (currently, or in the past).
18 Years
ALL
No
Sponsors
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Goldfinch Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Aventiv Research - Phoenix
Mesa, Arizona, United States
Glendale Adventist Medical Center
Glendale, California, United States
DaVita Mojave Sage Dialysis
Victorville, California, United States
Colorado Kidney Care
Denver, Colorado, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, United States
St. Clair Nephrology
Roseville, Michigan, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Clinical Research Consultants
Kansas City, Missouri, United States
DaVita Pelican Point Dialysis
Las Vegas, Nevada, United States
High Desert Nephrology
Gallup, New Mexico, United States
Akron Nephrology Associates, Inc.
Akron, Ohio, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Arlington Nephrology, PC
Arlington, Texas, United States
North Texas Kidney Disease Association
Lewisville, Texas, United States
South Texas Renal Care Group (Downtown)
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group (Wurzbach Road)
San Antonio, Texas, United States
South Texas Renal Care Group (Westover Hills)
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group (Carnoustie Drive)
San Antonio, Texas, United States
Countries
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Other Identifiers
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GFB-887-501
Identifier Type: -
Identifier Source: org_study_id
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