A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

Study Overview

• Status: Terminated
• Conditions: Kidney Diseases; Urologic Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetes Complications; Diabetic Nephropathies; Glomerulonephritis; Nephritis; Glomerulosclerosis, Focal Segmental; Nephrosis; Nephrosis, Lipoid
• Intervention / Treatment: Drug: GFB-887; Drug: Placebo

Detailed Description

Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35392
      • University of Alabama at Birmingham
  • Arizona
    • Mesa, Arizona, United States, 85210-6041
      • Aventiv Research - Phoenix
    • Scottsdale, Arizona, United States, 85258
      • Arizona Kidney Disease & Hypertension Centers (AKDHC)
  • California
    • Glendale, California, United States, 90022
      • Academic Medical Research Institute (AMRI)
    • Granada Hills, California, United States, 91344
      • Amicis Research Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Northridge, California, United States, 91324
      • Amicis Research Center
    • Northridge, California, United States, 91324
      • Valley Renal Medical Group
    • Palm Springs, California, United States, 92262
      • Respire Research - Palm Springs
    • S. Gate, California, United States, 90280
      • Dr. Malvin Yan Inc.
    • San Dimas, California, United States, 91773
      • North American Research Institute
    • Tarzana, California, United States, 91356
      • Valiance Clinical Research - Tarzana
    • Vacaville, California, United States, 95687
      • Amicis Research Center
    • Victorville, California, United States, 92395-8322
      • DaVita Mojave Sage Dialysis
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Denver, Colorado, United States, 80230
      • Colorado Kidney Care (Denver Nephrology)
    • Wheat Ridge, Colorado, United States, 80033
      • Western Nephrology - Westminster
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • DaVita Hartford North
  • Delaware
    • Newark, Delaware, United States, 19713
      • Nephrology Associationes, P.A.
  • Florida
    • Doral, Florida, United States, 33166
      • Prohealth Research Center - Doral
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners Leesburg, LLC
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute
    • Miami, Florida, United States, 33150
      • Kidney & Hypertension Specialists of Miami
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Port Charlotte, Florida, United States, 33952
      • Coastal Nephrology Associates Research Center, LLC
    • Winter Park, Florida, United States, 32789
      • Florida Premier Research Institute - Clay Street
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research, Inc.
    • Tyrone, Georgia, United States, 30290
      • Inova Clinical Trials and Research Center
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Boise Kidney and Hypertension Institute
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
    • Hinsdale, Illinois, United States, 60521
      • Adventist Health Partners
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Public Health
  • Kansas
    • Manhattan, Kansas, United States, 66502
      • My Kidney Center, LLC
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Louisiana Kidney Update, LLC
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center - School of Medicine - New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01107
      • Renal and Transplant Associates of New England, PC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University School of Medicine
    • Roseville, Michigan, United States, 48066
      • St. Clair Nephrology
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Davita Clinical Research
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota - Center for Pediatric Obesity Medicine
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
    • Tupelo, Mississippi, United States, 38801
      • Nephrology & Hypertension Associates Ltd
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • DaVita Pelican Point Dialysis
    • Reno, Nevada, United States, 89511
      • Sierra Nevada Nephrology Consultants
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Eastern Nephrology Associates PLLC
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron Nephrology Associates, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Rhode Island Hospital
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • South Carolina Nephrology and Hypertension
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Southeast Renal Research Institute
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Tech University Health Sciences Center - Amarillo
    • Arlington, Texas, United States, 76015
      • Arlington Nephrology, PC
    • Conroe, Texas, United States, 77304
      • Conroe Willis Medical Research
    • Dallas, Texas, United States, 75235
      • Renal Disease Research Institute
    • El Paso, Texas, United States, 79935
      • El Paso Kidney Specialists, PA
    • Houston, Texas, United States, 77036
      • Xpress Trials LLC
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center
    • Lewisville, Texas, United States, 75057-6039
      • North Texas Kidney Disease Association
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
    • San Antonio, Texas, United States, 78258
      • San Antonio Kidney Disease Center Physicians Group, PLLC
    • Webster, Texas, United States, 77598
      • Clear Lake Specialties
  • Utah
    • Salt Lake City, Utah, United States, 84115
      • Utah Kidney Research Institute
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Kidney Specialists - Riverview
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients:

  1. Male or female 18-75 years of age, of any race, at the time of signing informed consent.
  2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
  3. Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

• For DN patients:

  1. Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
  2. UACR ≥ 150 mg/g.

• For FSGS/TR-MCD patients:

  1. Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
  2. UPCR ≥ 1.0 g/g.

Exclusion Criteria:

• All patients:

  1. Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
  2. History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
  3. History of any organ or bone marrow transplant, including kidney grafts.
  4. History of alcoholism or drug/chemical abuse within 12 months prior to Screening.

• For DN patients:

  1. Renal disease that requires immunosuppressive therapy (currently, or in the past).
  2. Body mass index (BMI) >45 kg/m2.

• For FSGS/TR-MCD patients:

  1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
  2. Body mass index (BMI) >40 kg/m2.
  3. Known history of severe or chronic hepatobiliary disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GFB-887 multiple ascending dose (MAD) active; GFB-887 active once-daily dosing	Drug: GFB-887; Investigational Medicinal Product (IMP)
Placebo Comparator: GFB-887 MAD placebo; GFB-887 placebo once-daily dosing	Drug: Placebo; Matching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)	12 weeks
Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of FSGS/TR-MCD patients achieving a modified partial remission	12 weeks
Proportion of FSGS/TR-MCD patients achieving a complete remission	12 weeks
Percentage change in 24-hour urine protein excretion	12 weeks
Percentage change in 24-hour urine albumin excretion	12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline	12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline	12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline	12 weeks
Incidence and severity of adverse events	12 weeks
Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations	Approximately 12 weeks
Incidence of clinically significant changes in laboratory parameters	12 weeks
Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax)	12 weeks
Plasma PK parameters: time of the observed plasma concentration (Tmax)	12 weeks
Plasma PK parameters: area under the plasma concentration-time curve (AUC)	12 weeks

Collaborators and Investigators

• Sponsor: Goldfinch Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Glomerulonephritis; Nephritis; Endocrine System Diseases; Glomerulosclerosis, Focal Segmental; Diabetes Complications; Nephrotic Syndrome; Nephrosis; Urologic Diseases; Nephrosis, Lipoid
• Other Study ID Numbers: GFB-887-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No