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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) | Clinical Trials | Clareo Health

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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)

A Study to Characterize the Genetic, Biomarker, and Clinical Profile of Patients With Focal Segmental Glomerulosclerosis (FSGS), Treatment-Resistant Minimal Change Disease (TR-MCD), and Diabetic Nephropathy (DN)

NCT04235621•Goldfinch Bio, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For FSGS/TR-MCD 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 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
+2 more criteria

Exclusion Criteria

•For FSGS/TR-MCD patients:
•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:
+9 more criteria

Locations (18)

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

Key Dates

Start Date

December 20, 2019

Primary Completion Date

May 27, 2020

Completion Date

May 27, 2020

Last Updated

July 20, 2021

Enrollment

ACTUAL participants

Conditions

Glomerulosclerosis, Focal SegmentalMinimal Change DiseaseDiabetic Nephropathies

Interventions

FSGS/TR-MCD

OTHER

Diabetic Nephropathy (DN)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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