Currently Enrolling
Interventional

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

Swarnam Chiramel

Email Phone (224) 500-6107
Site Name

NANI Nephrology
911 N Elm St Ste 102, Hinsdale, IL 60421-3640

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

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Currently Enrolling
Interventional

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.

Hinsdale, IL
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions