Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
TRACTION-2
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
Brief Description
GFB-887-201 is an interventional study comparing GFB-887 to placebo in patients with focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), and diabetic nephropathy (DN).
Trial Physician / Study Coordinator
Angelic Garay
EmailSite Name
DaVita Pelican Point Dialysis
2421 Tech Center Ct., Suite 108, Las Vegas, NV 89128
Sponsor
Goldfinch Bio
Study Drug
GFB-887
Estimated enrollment
Up to 125 patients FSGS / TR-MCD or DN are planned to be enrolled into the study.
Estimated end date
TBC
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
TRACTION-2
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
Brief Description
GFB-887-201 is an interventional study comparing GFB-887 to placebo in patients with focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), and diabetic nephropathy (DN).
Trial is for people with
Focal Segmental Glomerulosclerosis (FSGS), Treatment- Resistant Minimal Change Disease (TR-MCD), and Diabetic Nephropathy (DN), between 18 and 75 years of age
Study Goal
The purpose of this study is to evaluate the safety and efficacy of GFB-887 for the treatment of Diabetic Nephropathy (DN), Focal Segmental Glomerulosclerosis (FSGS), and Treatment-Resistant Minimal Change Disease (TR-MCD).
What is involved for the Patient?
The trial doctor or trial staff will also explain all aspects of the trial to you and answer your questions.
1. Informed consent process (decide if you want to take part in the trial)
-Review all details of TRACTION-2 with the trial doctor or trial staff.
-Ask questions about any aspects of the trial that are unclear to you.
-Take as much time as you need to consider participating.
-Discuss the trial with your doctor and your family and friends.
-Sign the consent form (if you want to take part in the trial).
-Even if you choose to take part in the trial and sign the consent form, you are still free to leave the trial at any time without giving a reason.
2. Screening (find out if you qualify to take part in the trial)
-Answer questions about your medical history, your medications, and treatments you may have received.
-Have medical tests and procedures done to determine if you meet all of the requirements for taking part in the trial.
3. Taking part in the trial
-Take your trial drug (GFB-887 or placebo) as instructed.
-Attend up to 17 scheduled trial visits over a period of approximately 26 weeks. Some visits may take place at your home or by phone.
-Complete required trial activities, including blood draws, physical exams, questionnaires, and urine sample collections. There are other activities that the trial doctor and trial staff will discuss with you.
About the drug or intervention
GFB-887 is an experimental drug that is not approved by the U.S. Food and Drug Administration (FDA). It is being investigated for the treatment of DN, FSGS, or TR-MCD.
Currently, there are no approved therapies in the US to specifically treat FSGS or TR-MCD. Despite current treatments for DN, patients continue to experience progressive loss of kidney function. Given this, there is a need to develop new therapies to treat patients with DN, FSGS, and TR-MCD. Researchers hope that GFB-887 will slow or halt progression of kidney failure by inhibiting a target called TRPC5. TRPC5 is thought to play a role in in the progression of kidney diseases like DN, FSGS and TR-MCD.