A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
NCT ID: NCT04387448
Last Updated: 2022-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
96 participants
INTERVENTIONAL
2020-07-28
2022-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
NCT04950114
A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT04578548
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)
NCT04235621
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
NCT03448692
Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
NCT00464321
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GFB-887 multiple ascending dose (MAD) active
GFB-887 active once-daily dosing
GFB-887
Investigational Medicinal Product (IMP)
GFB-887 MAD placebo
GFB-887 placebo once-daily dosing
Placebo
Matching
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GFB-887
Investigational Medicinal Product (IMP)
Placebo
Matching
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Goldfinch Bio, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Aventiv Research - Phoenix
Mesa, Arizona, United States
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Scottsdale, Arizona, United States
Academic Medical Research Institute (AMRI)
Glendale, California, United States
Amicis Research Center
Granada Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Valley Renal Medical Group
Northridge, California, United States
Respire Research - Palm Springs
Palm Springs, California, United States
North American Research Institute
San Dimas, California, United States
Dr. Malvin Yan Inc.
South Gate, California, United States
Valiance Clinical Research - Tarzana
Tarzana, California, United States
Amicis Research Center
Vacaville, California, United States
DaVita Mojave Sage Dialysis
Victorville, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Kidney Care (Denver Nephrology)
Denver, Colorado, United States
Western Nephrology - Westminster
Wheat Ridge, Colorado, United States
DaVita Hartford North
Hartford, Connecticut, United States
Nephrology Associationes, P.A.
Newark, Delaware, United States
Prohealth Research Center - Doral
Doral, Florida, United States
Clinical Site Partners Leesburg, LLC
Leesburg, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
Kidney & Hypertension Specialists of Miami
Miami, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Coastal Nephrology Associates Research Center, LLC
Port Charlotte, Florida, United States
Florida Premier Research Institute - Clay Street
Winter Park, Florida, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, United States
Inova Clinical Trials and Research Center
Tyrone, Georgia, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States
Research by Design, LLC
Chicago, Illinois, United States
Adventist Health Partners
Hinsdale, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
University of Iowa College of Public Health
Iowa City, Iowa, United States
My Kidney Center, LLC
Manhattan, Kansas, United States
Louisiana Kidney Update, LLC
Lafayette, Louisiana, United States
Louisiana State University Health Sciences Center - School of Medicine - New Orleans
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
St. Clair Nephrology
Roseville, Michigan, United States
DaVita Clinical Research
Edina, Minnesota, United States
University of Minnesota - Center for Pediatric Obesity Medicine
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Nephrology & Hypertension Associates Ltd
Tupelo, Mississippi, United States
Clinical Research Consultants
Kansas City, Missouri, United States
DaVita Pelican Point Dialysis
Las Vegas, Nevada, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Eastern Nephrology Associates PLLC
New Bern, North Carolina, United States
Akron Nephrology Associates, Inc.
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
South Carolina Nephrology and Hypertension
Orangeburg, South Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center - Amarillo
Amarillo, Texas, United States
Arlington Nephrology, PC
Arlington, Texas, United States
Conroe Willis Medical Research
Conroe, Texas, United States
Renal Disease Research Institute
Dallas, Texas, United States
El Paso Kidney Specialists, PA
El Paso, Texas, United States
Xpress Trials LLC
Houston, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
North Texas Kidney Disease Association
Lewisville, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, United States
Clear Lake Specialties
Webster, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Tidewater Kidney Specialists - Riverview
Norfolk, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GFB-887-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.