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

NCT04387448 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: GFB-887-201
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 74

Brief Summary

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).

Conditions

Kidney Diseases; Diabetic Nephropathies; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Nephrosis

Outcome Measures

Primary Outcomes (2)

• Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)

  12 weeks

• Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)

  12 weeks

Secondary Outcomes (13)

• 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

Study Arms (2)

GFB-887 multiple ascending dose (MAD) active

EXPERIMENTAL

GFB-887 active once-daily dosing

Drug: GFB-887

GFB-887 MAD placebo

PLACEBO COMPARATOR

GFB-887 placebo once-daily dosing

Drug: Placebo

Interventions

GFB-887 DRUG

Investigational Medicinal Product (IMP)

GFB-887 multiple ascending dose (MAD) active

Placebo DRUG

Matching

GFB-887 MAD placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients:
• Male or female 18-75 years of age, of any race, at the time of signing informed consent.
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
• Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
• For DN patients:
• Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
• UACR ≥ 150 mg/g.
• For FSGS/TR-MCD patients:
• Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
• UPCR ≥ 1.0 g/g.

You may not qualify if:

• All patients:
• Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
• 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.
• History of any organ or bone marrow transplant, including kidney grafts.
• History of alcoholism or drug/chemical abuse within 12 months prior to Screening.
• For DN patients:
• Renal disease that requires immunosuppressive therapy (currently, or in the past).
• Body mass index (BMI) \>45 kg/m2.
• For FSGS/TR-MCD patients:
• Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
• Body mass index (BMI) \>40 kg/m2.
• Known history of severe or chronic hepatobiliary disease.

Sponsors & Collaborators

• Goldfinch Bio, Inc.: lead

Study Sites (74)

University of Alabama at Birmingham

Birmingham, Alabama, 35392, United States

Location

Aventiv Research - Phoenix

Mesa, Arizona, 85210-6041, United States

Location

Arizona Kidney Disease & Hypertension Centers (AKDHC)

Scottsdale, Arizona, 85258, United States

Location

Academic Medical Research Institute (AMRI)

Glendale, California, 90022, United States

Location

Amicis Research Center

Granada Hills, California, 91344, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Valley Renal Medical Group

Northridge, California, 91324, United States

Location

Respire Research - Palm Springs

Palm Springs, California, 92262, United States

Location

North American Research Institute

San Dimas, California, 91773, United States

Location

Dr. Malvin Yan Inc.

South Gate, California, 90280, United States

Location

Valiance Clinical Research - Tarzana

Tarzana, California, 91356, United States

Location

Amicis Research Center

Vacaville, California, 95687, United States

Location

DaVita Mojave Sage Dialysis

Victorville, California, 92395-8322, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Colorado Kidney Care (Denver Nephrology)

Denver, Colorado, 80230, United States

Location

Western Nephrology - Westminster

Wheat Ridge, Colorado, 80033, United States

Location

DaVita Hartford North

Hartford, Connecticut, 06112, United States

Location

Nephrology Associationes, P.A.

Newark, Delaware, 19713, United States

Location

Prohealth Research Center - Doral

Doral, Florida, 33166, United States

Location

Clinical Site Partners Leesburg, LLC

Leesburg, Florida, 34748, United States

Location

Premier Clinical Research Institute

Miami, Florida, 33122, United States

Location

Kidney & Hypertension Specialists of Miami

Miami, Florida, 33150, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

Coastal Nephrology Associates Research Center, LLC

Port Charlotte, Florida, 33952, United States

Location

Florida Premier Research Institute - Clay Street

Winter Park, Florida, 32789, United States

Location

Masters of Clinical Research, Inc.

Augusta, Georgia, 30909, United States

Location

Inova Clinical Trials and Research Center

Tyrone, Georgia, 30290, United States

Location

Boise Kidney and Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

Adventist Health Partners

Hinsdale, Illinois, 60521, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

University of Iowa College of Public Health

Iowa City, Iowa, 52242, United States

Location

My Kidney Center, LLC

Manhattan, Kansas, 66502, United States

Location

Louisiana Kidney Update, LLC

Lafayette, Louisiana, 70506, United States

Location

Louisiana State University Health Sciences Center - School of Medicine - New Orleans

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Renal and Transplant Associates of New England, PC

Springfield, Massachusetts, 01107, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

St. Clair Nephrology

Roseville, Michigan, 48066, United States

Location

DaVita Clinical Research

Edina, Minnesota, 55435, United States

Location

University of Minnesota - Center for Pediatric Obesity Medicine

Minneapolis, Minnesota, 55414, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Nephrology & Hypertension Associates Ltd

Tupelo, Mississippi, 38801, United States

Location

Clinical Research Consultants

Kansas City, Missouri, 64111, United States

Location

DaVita Pelican Point Dialysis

Las Vegas, Nevada, 89129, United States

Location

Sierra Nevada Nephrology Consultants

Reno, Nevada, 89511, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Eastern Nephrology Associates PLLC

New Bern, North Carolina, 28562, United States

Location

Akron Nephrology Associates, Inc.

Akron, Ohio, 44302, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

Rhode Island Hospital

East Providence, Rhode Island, 02915, United States

Location

South Carolina Nephrology and Hypertension

Orangeburg, South Carolina, 29118, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Sciences Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Arlington Nephrology, PC

Arlington, Texas, 76015, United States

Location

Conroe Willis Medical Research

Conroe, Texas, 77304, United States

Location

Renal Disease Research Institute

Dallas, Texas, 75235, United States

Location

El Paso Kidney Specialists, PA

El Paso, Texas, 79935, United States

Location

Xpress Trials LLC

Houston, Texas, 77036, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

North Texas Kidney Disease Association

Lewisville, Texas, 75057-6039, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

San Antonio Kidney Disease Center Physicians Group, PLLC

San Antonio, Texas, 78258, United States

Location

Clear Lake Specialties

Webster, Texas, 77598, United States

Location

Utah Kidney Research Institute

Salt Lake City, Utah, 84115, United States

Location

Tidewater Kidney Specialists - Riverview

Norfolk, Virginia, 23502, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Diabetic Nephropathies; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Nephrosis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple-ascending, placebo-controlled

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: July 28, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (74)