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)

July 17, 2021 updated by: Goldfinch Bio, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210-6041
        • Aventiv Research - Phoenix
    • California
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • Victorville, California, United States, 92395-8322
        • DaVita Mojave Sage Dialysis
    • Colorado
      • Denver, Colorado, United States, 80230-7200
        • Colorado Kidney Care
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107-1369
        • Renal and Transplant Associates of New England, PC
    • Michigan
      • Roseville, Michigan, United States, 48066
        • St. Clair Nephrology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404-1212
        • DaVita Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants
    • Nevada
      • Las Vegas, Nevada, United States, 89129-6201
        • DaVita Pelican Point Dialysis
    • New Mexico
      • Gallup, New Mexico, United States, 87301-5655
        • High Desert Nephrology
    • Ohio
      • Akron, Ohio, United States, 44302-1715
        • Akron Nephrology Associates, Inc.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-2743
        • Southeast Renal Research Institute
    • Texas
      • Arlington, Texas, United States, 76015
        • Arlington Nephrology, PC
      • Lewisville, Texas, United States, 75057-6039
        • North Texas Kidney Disease Association
      • San Antonio, Texas, United States, 78207
        • South Texas Renal Care Group (Downtown)
      • San Antonio, Texas, United States, 78229-3809
        • San Antonio Kidney Disease Center Physicians Group (Wurzbach Road)
      • San Antonio, Texas, United States, 78251-1230
        • South Texas Renal Care Group (Westover Hills)
      • San Antonio, Texas, United States, 78258-4800
        • San Antonio Kidney Disease Center Physicians Group (Carnoustie Drive)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be drawn from participating investigators' clinics

Description

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
  4. Urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g.
  5. Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2.

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:

  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FSGS/TR-MCD
Patients with FSGS/TR-MCD
Other: FSGS/TR-MCD
This is a non-interventional study
Diabetic Nephropathy (DN)
Patients with DN
Other: Diabetic Nephropathy (DN)
This is a non-interventional study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Urine Protein-to-Creatinine Ratio (UPCR)
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame: Approximately 1 year
Approximately 1 year
Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline/Biomarker collection visit
Baseline/Biomarker collection visit
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Approximately 8 weeks
Approximately 8 weeks
Change in Urine Biomarker: Nephrin
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Biomarker: Podocin
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Biomarker: Rac1
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Biomarker: Synaptopodin
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Biomarker: Urea
Time Frame: Approximately 1 year
Approximately 1 year
Change in Urine Biomarker: Other Exploratory
Time Frame: Approximately 1 year
Approximately 1 year
Change in Serum/Plasma Biomarker: Other Exploratory
Time Frame: Approximately 8 weeks
Approximately 8 weeks
Number of patients with genetic variants predicted to be associated with chronic kidney disease and functional consequence
Time Frame: Baseline/Biomarker collection visit
DNA analysis of blood sample
Baseline/Biomarker collection visit
Gene expression profile and phenotype of inducible pluripotent stem cell (iPSC)-generated organoids
Time Frame: Baseline/Biomarker collection visit
Generation of iPSC from whole blood sample
Baseline/Biomarker collection visit
Change from Baseline Patient-reported Assessment of FSGS Symptoms
Time Frame: Approximately 8 weeks
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
Time Frame: Approximately 8 weeks
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
Time Frame: Approximately 8 weeks
Patients will assess the symptom of fatigue utilizing the Modified Fatigue Impact Scale
Approximately 8 weeks
Change from Baseline Clinician-reported Assessment of Edema
Time Frame: Approximately 8 weeks
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
Time Frame: Approximately 1 year
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
Time Frame: Approximately 1 year
Change in treatment as indicated by patient medical record
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goldfinch Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GFB-887-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient reported outcome (and other relevant data) will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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