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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04387448
• Other study ID #: GFB-887-201
• Status: Terminated
• Phase: Phase 2
• Start date: July 28, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Goldfinch Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GFB-887
Investigational Medicinal Product (IMP)
• Placebo
Matching

Locations

Country	Name	City	State
United States	Akron Nephrology Associates, Inc.	Akron	Ohio
United States	Texas Tech University Health Sciences Center - Amarillo	Amarillo	Texas
United States	University of Michigan	Ann Arbor	Michigan
United States	Arlington Nephrology, PC	Arlington	Texas
United States	Masters of Clinical Research, Inc.	Augusta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	Research by Design, LLC	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Conroe Willis Medical Research	Conroe	Texas
United States	Renal Disease Research Institute	Dallas	Texas
United States	Colorado Kidney Care (Denver Nephrology)	Denver	Colorado
United States	Wayne State University School of Medicine	Detroit	Michigan
United States	Prohealth Research Center - Doral	Doral	Florida
United States	Rhode Island Hospital	East Providence	Rhode Island
United States	DaVita Clinical Research	Edina	Minnesota
United States	El Paso Kidney Specialists, PA	El Paso	Texas
United States	Academic Medical Research Institute (AMRI)	Glendale	California
United States	Amicis Research Center	Granada Hills	California
United States	DaVita Hartford North	Hartford	Connecticut
United States	Adventist Health Partners	Hinsdale	Illinois
United States	Prolato Clinical Research Center	Houston	Texas
United States	Xpress Trials LLC	Houston	Texas
United States	University of Iowa College of Public Health	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Clinical Research Consultants	Kansas City	Missouri
United States	Louisiana Kidney Update, LLC	Lafayette	Louisiana
United States	DaVita Pelican Point Dialysis	Las Vegas	Nevada
United States	Clinical Site Partners Leesburg, LLC	Leesburg	Florida
United States	North Texas Kidney Disease Association	Lewisville	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	My Kidney Center, LLC	Manhattan	Kansas
United States	Boise Kidney and Hypertension Institute	Meridian	Idaho
United States	Aventiv Research - Phoenix	Mesa	Arizona
United States	Kidney & Hypertension Specialists of Miami	Miami	Florida
United States	Premier Clinical Research Institute	Miami	Florida
United States	University of Minnesota - Center for Pediatric Obesity Medicine	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Eastern Nephrology Associates PLLC	New Bern	North Carolina
United States	Louisiana State University Health Sciences Center - School of Medicine - New Orleans	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Nephrology Associationes, P.A.	Newark	Delaware
United States	Tidewater Kidney Specialists - Riverview	Norfolk	Virginia
United States	Amicis Research Center	Northridge	California
United States	Valley Renal Medical Group	Northridge	California
United States	South Carolina Nephrology and Hypertension	Orangeburg	South Carolina
United States	Respire Research - Palm Springs	Palm Springs	California
United States	Avanza Medical Research Center	Pensacola	Florida
United States	Coastal Nephrology Associates Research Center, LLC	Port Charlotte	Florida
United States	Sierra Nevada Nephrology Consultants	Reno	Nevada
United States	St. Clair Nephrology	Roseville	Michigan
United States	Dr. Malvin Yan Inc.	S. Gate	California
United States	Utah Kidney Research Institute	Salt Lake City	Utah
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	San Antonio Kidney Disease Center Physicians Group, PLLC	San Antonio	Texas
United States	North American Research Institute	San Dimas	California
United States	Arizona Kidney Disease & Hypertension Centers (AKDHC)	Scottsdale	Arizona
United States	Providence Medical Research Center	Spokane	Washington
United States	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Valiance Clinical Research - Tarzana	Tarzana	California
United States	Nephrology & Hypertension Associates Ltd	Tupelo	Mississippi
United States	Inova Clinical Trials and Research Center	Tyrone	Georgia
United States	Amicis Research Center	Vacaville	California
United States	DaVita Mojave Sage Dialysis	Victorville	California
United States	Clear Lake Specialties	Webster	Texas
United States	Western Nephrology - Westminster	Wheat Ridge	Colorado
United States	Florida Premier Research Institute - Clay Street	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Goldfinch Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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