Back to resultsA Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
Primary Purpose
Kidney Diseases, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GFB-887
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- University of Alabama at Birmingham
- Aventiv Research - Phoenix
- Arizona Kidney Disease & Hypertension Centers (AKDHC)
- Academic Medical Research Institute (AMRI)
- Amicis Research Center
- Cedars-Sinai Medical Center
- Amicis Research Center
- Valley Renal Medical Group
- Respire Research - Palm Springs
- Dr. Malvin Yan Inc.
- North American Research Institute
- Valiance Clinical Research - Tarzana
- Amicis Research Center
- DaVita Mojave Sage Dialysis
- University of Colorado Anschutz Medical Campus
- Colorado Kidney Care (Denver Nephrology)
- Western Nephrology - Westminster
- DaVita Hartford North
- Nephrology Associationes, P.A.
- Prohealth Research Center - Doral
- Clinical Site Partners Leesburg, LLC
- Premier Clinical Research Institute
- Kidney & Hypertension Specialists of Miami
- Avanza Medical Research Center
- Coastal Nephrology Associates Research Center, LLC
- Florida Premier Research Institute - Clay Street
- Masters of Clinical Research, Inc.
- Inova Clinical Trials and Research Center
- Boise Kidney and Hypertension Institute
- Research by Design, LLC
- Adventist Health Partners
- Southern Illinois University School of Medicine
- University of Iowa College of Public Health
- My Kidney Center, LLC
- Louisiana Kidney Update, LLC
- Louisiana State University Health Sciences Center - School of Medicine - New Orleans
- University of Maryland Medical Center
- Tufts Medical Center
- Renal and Transplant Associates of New England, PC
- University of Michigan
- Wayne State University School of Medicine
- St. Clair Nephrology
- DaVita Clinical Research
- University of Minnesota - Center for Pediatric Obesity Medicine
- University of Mississippi Medical Center
- Nephrology & Hypertension Associates Ltd
- Clinical Research Consultants
- DaVita Pelican Point Dialysis
- Sierra Nevada Nephrology Consultants
- Mount Sinai Medical Center
- Columbia University Medical Center
- Eastern Nephrology Associates PLLC
- Akron Nephrology Associates, Inc.
- Cleveland Clinic
- The Ohio State University Wexner Medical Center
- Northeast Clinical Research Center
- Rhode Island Hospital
- South Carolina Nephrology and Hypertension
- Southeast Renal Research Institute
- Vanderbilt University Medical Center
- Texas Tech University Health Sciences Center - Amarillo
- Arlington Nephrology, PC
- Conroe Willis Medical Research
- Renal Disease Research Institute
- El Paso Kidney Specialists, PA
- Xpress Trials LLC
- Prolato Clinical Research Center
- North Texas Kidney Disease Association
- Clinical Advancement Center, PLLC
- San Antonio Kidney Disease Center Physicians Group, PLLC
- Clear Lake Specialties
- Utah Kidney Research Institute
- Tidewater Kidney Specialists - Riverview
- Providence Medical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GFB-887 multiple ascending dose (MAD) active
GFB-887 MAD placebo
Arm Description
GFB-887 active once-daily dosing
GFB-887 placebo once-daily dosing
Outcomes
Primary Outcome Measures
Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)
Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)
Secondary Outcome Measures
Proportion of FSGS/TR-MCD patients achieving a modified partial remission
Proportion of FSGS/TR-MCD patients achieving a complete remission
Percentage change in 24-hour urine protein excretion
Percentage change in 24-hour urine albumin excretion
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline
Incidence and severity of adverse events
Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations
Incidence of clinically significant changes in laboratory parameters
Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax)
Plasma PK parameters: time of the observed plasma concentration (Tmax)
Plasma PK parameters: area under the plasma concentration-time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04387448
Brief Title
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Goldfinch Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Glomerulonephritis, Nephritis, Nephrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multiple-ascending, placebo-controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GFB-887 multiple ascending dose (MAD) active
Arm Type
Experimental
Arm Description
GFB-887 active once-daily dosing
Arm Title
GFB-887 MAD placebo
Arm Type
Placebo Comparator
Arm Description
GFB-887 placebo once-daily dosing
Intervention Type
Drug
Intervention Name(s)
GFB-887
Intervention Description
Investigational Medicinal Product (IMP)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching
Primary Outcome Measure Information:
Title
Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)
Time Frame
12 weeks
Title
Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of FSGS/TR-MCD patients achieving a modified partial remission
Time Frame
12 weeks
Title
Proportion of FSGS/TR-MCD patients achieving a complete remission
Time Frame
12 weeks
Title
Percentage change in 24-hour urine protein excretion
Time Frame
12 weeks
Title
Percentage change in 24-hour urine albumin excretion
Time Frame
12 weeks
Title
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline
Time Frame
12 weeks
Title
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline
Time Frame
12 weeks
Title
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline
Time Frame
12 weeks
Title
Incidence and severity of adverse events
Time Frame
12 weeks
Title
Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations
Time Frame
Approximately 12 weeks
Title
Incidence of clinically significant changes in laboratory parameters
Time Frame
12 weeks
Title
Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax)
Time Frame
12 weeks
Title
Plasma PK parameters: time of the observed plasma concentration (Tmax)
Time Frame
12 weeks
Title
Plasma PK parameters: area under the plasma concentration-time curve (AUC)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35392
Country
United States
Facility Name
Aventiv Research - Phoenix
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210-6041
Country
United States
Facility Name
Arizona Kidney Disease & Hypertension Centers (AKDHC)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Academic Medical Research Institute (AMRI)
City
Glendale
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Amicis Research Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Amicis Research Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Valley Renal Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Respire Research - Palm Springs
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Dr. Malvin Yan Inc.
City
S. Gate
State/Province
California
ZIP/Postal Code
90280
Country
United States
Facility Name
North American Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Valiance Clinical Research - Tarzana
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Amicis Research Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
DaVita Mojave Sage Dialysis
City
Victorville
State/Province
California
ZIP/Postal Code
92395-8322
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Kidney Care (Denver Nephrology)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Western Nephrology - Westminster
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
DaVita Hartford North
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Facility Name
Nephrology Associationes, P.A.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Prohealth Research Center - Doral
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Clinical Site Partners Leesburg, LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Premier Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Kidney & Hypertension Specialists of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
Country
United States
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Coastal Nephrology Associates Research Center, LLC
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Florida Premier Research Institute - Clay Street
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Masters of Clinical Research, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Inova Clinical Trials and Research Center
City
Tyrone
State/Province
Georgia
ZIP/Postal Code
30290
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Adventist Health Partners
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Iowa College of Public Health
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
My Kidney Center, LLC
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Louisiana Kidney Update, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Louisiana State University Health Sciences Center - School of Medicine - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Renal and Transplant Associates of New England, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Clair Nephrology
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
DaVita Clinical Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Minnesota - Center for Pediatric Obesity Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Nephrology & Hypertension Associates Ltd
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
DaVita Pelican Point Dialysis
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Sierra Nevada Nephrology Consultants
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Eastern Nephrology Associates PLLC
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Akron Nephrology Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Rhode Island Hospital
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
South Carolina Nephrology and Hypertension
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Tech University Health Sciences Center - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Arlington Nephrology, PC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Conroe Willis Medical Research
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
El Paso Kidney Specialists, PA
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Xpress Trials LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
North Texas Kidney Disease Association
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057-6039
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Clear Lake Specialties
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Utah Kidney Research Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Tidewater Kidney Specialists - Riverview
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
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