Do You Have Chronic Kidney Disease?

The TRACTION-2 clinical research trial is evaluating an investigational product called GFB-887 for the potential treatment of focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), and diabetic nephropathy (DN). The purpose of the trial is to determine if GFB-887 is safe and may help people who have high levels of protein in their urine due to their kidney disease.

You can find out if you may qualify to take part in TRACTION-2 by answering a few questions. Depending on your answers, you may be referred to a trial site for screening.

Am I Eligible?

Your doctor can also help you find out if you may qualify for TRACTION-2. You can give your doctor the clinicaltrials.gov reference number: NCT04387448.

Research

Patients with progressive kidney disease may benefit from therapeutic options tailored to their specific conditions. Clinical trials are researching options that may have the potential to slow disease progression and preserve kidney function for these patients.

  • Currently, there is no therapy approved in the United States with a specific indication for treatment of focal segmental glomerulosclerosis (FSGS) or treatment-resistant minimal change disease (TR-MCD).
  • Patients with diabetic nephropathy (DN) continue to experience progressive loss of kidney function despite overall improvements in controlling blood sugar levels and blood pressure.
  • TRACTION-2 is evaluating GFB-887 as a potential therapeutic option for people living with FSGS, TR-MCD, or DN.

About GFB-887

GFB-887 is an oral investigational product that has not been approved for any use by the U.S. Food and Drug Administration (FDA) or any other regulatory agency.


Kidney diseases like focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), and diabetic nephropathy (DN) are progressive, meaning they get worse over time. It is believed that this worsening of disease results from special kidney cells called podocytes being injured. Researchers are looking to see if GFB-887 may help slow or halt progression of kidney failure by preventing podocyte injury.

What is TRACTION-2?

TRACTION-2 is a clinical research trial for people with kidney disease, specifically focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), or diabetic nephropathy (DN). The purpose of this trial is to determine if the investigational product (GFB-887) is safe and may help people with high levels of protein in their urine due to their kidney disease.

What should I expect?

The following is only a summary. Additional details are provided in the Trial FAQs. 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.

Am I Eligible?

To begin the process of finding out if you may qualify to take part in TRACTION-2, click the box for any of the following statements that apply to you.

  • I am 18 – 75 years of age.
  • I have been diagnosed with or I am being treated for focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), or diabetic nephropathy (DN).

You may be a potential candidate for this trial.

Next

Where is the trial happening?

The TRACTION-2 trial is happening at sites across the United States. Trial sites may continue to be added. Click a pin on the map or select a location from the list to view site information.

Clinical trials, also referred to as clinical studies, are how new treatment options for diseases and health conditions are developed. These trials provide valuable information about safety and efficacy before an investigational product may be approved.
Clinical trials follow a specific set of standards and are regulated to help protect trial participants. An independent Ethics Committee (EC) or an Institutional Review Board (IRB) reviews and monitors each trial closely to safeguard the rights and welfare of participants. Nevertheless, clinical trials have risks, including the potential for participants to experience side effects. The trial doctor or trial staff will discuss potential risks with you before you decide if you want to take part in the trial.
The investigational product is called GFB-887.

If you meet all requirements for taking part in the trial and you choose to join the trial, you will be randomly assigned (like the flip of a coin) to receive either:

  • GFB-887
    OR
  • Placebo (an inactive drug product that looks like GFB-887)

Neither you nor the trial doctor or trial staff will know if you receive GFB-887 or the placebo until after the trial has ended and the results have been analyzed.

You will take your assigned trial drug (GFB-887 or placebo) daily, by mouth. The trial doctor or trial staff will give you a supply of trial drug along with instructions for taking it.

The placebo is an inactive drug product that looks like GFB-887. The placebo is used because comparing results in trial participants who receive GFB-887 with results in trial participants who receive placebo is the best way to explore how well GFB-887 works and how safe it is.

If you decide to take part in this trial, it is important that you agree to:

  • Complete all trial visits and contact the trial staff if you need to reschedule.
  • Tell your trial doctor or trial staff about any changes in your health, including visits to other doctors or hospital admissions, or if you or your partner may be pregnant.
  • Contact your trial doctor or trial staff before making any changes regarding medications you take, including over-the-counter medications, herbal remedies, and vitamins.
  • Take, handle, and store the trial drug as instructed and return unused trial drug and all packaging at each trial visit.
  • Avoid major changes to your protein intake and follow all instructions regarding dietary restrictions and physical activity.
  • Collect urine samples at home according to the instructions given to you by your trial doctor or trial staff.
  • Tell your trial doctor or trial staff if you change your mind about being in the trial.
  • Do not take part in any other clinical research trials without the consent of your trial doctor while you are taking part in this trial.

Trial procedures and assessments help the trial doctor and trial staff check on your health and any effects of the trial drug (GFB-887 or placebo). It may be possible to have a trial nurse visit you at home to conduct some (but not all) of your visits. You may also have some visits by phone call, and you will need to complete some activities on your own at home.

Screening activities

  • Questions about your medical history, your medications, and treatments you may have received
  • Collection of information about your age, race, and ethnicity
  • Blood samples
  • Urine samples
  • Vital signs (blood pressure, oral temperature, pulse rate, respiratory rate)
  • Weight and height measurements
  • Physical exam
  • Electrocardiogram (ECG; heart rhythm tracing)
  • Home urine sample collection (collect and store a urine sample from your first morning void over 3 consecutive days directly after your screening visit)

Activities at EVERY on-site or home nursing trial visit

  • Questions about symptoms, illnesses, and medication changes
  • Blood samples
  • Urine samples
  • Vital signs (blood pressure, oral temperature, pulse rate, respiratory rate)

Activities at SOME on-site or home nursing trial visits

  • Weight measurement
  • Physical exam
  • Electrocardiogram (ECG; heart rhythm tracing)
  • Assessment of edema
  • Health-related questionnaires

Activities for phone calls

  • Questions about symptoms, illnesses, and medication changes

Other activities: Urine sample collections at home

You will be asked to collect and store a urine sample from your first morning void over 3 consecutive days. The trial site will provide you with materials and instructions on how this sample is to be collected, stored, and sent back to the trial lab.

If you are not able to go to your trial site for reasons related to a public health emergency (for example, you don’t feel well or local guidelines do not permit you to go to the site), the trial doctor or staff will provide instructions for completing trial visit activities. These may include:

  • The use of an application on your phone or computer (telemedicine)
  • A phone call
  • A home nursing visit or travel to another location (if blood needs to be drawn)

Taking part in this trial is entirely voluntary. If you choose to take part and you change your mind later, you are free to leave the trial at any time without giving a reason. If you leave the trial early, you will be asked to return for a final visit.

Your choice to take part or to stop taking part in this trial will not affect your routine/regular treatment, your relationship with those treating you, or your relationship with the place where you are getting treatment. You will still receive care for your condition and will not lose any benefits to which you are otherwise entitled.

There may be a risk that GFB-887 will have an effect on other drugs. This is known as a drug-drug interaction. To reduce this risk, your trial doctor and trial staff will review the medications you are taking and closely monitor you for potential drug-drug interactions. You will need to contact your trial doctor or trial staff before making any changes regarding medications you take, including over-the-counter medications, herbal remedies, and vitamins.
You can visit any doctor to meet your health needs during the trial. You should tell other medical professionals you see that you are participating in a clinical trial and always communicate openly with your trial doctor regarding other care you receive.
You may be eligible to receive compensation for your time and reasonable out-of-pocket expenses related to taking part in this trial. For more information, please talk to your trial doctor and trial staff.
You will receive the trial drug (GFB-887 or placebo) and trial-specific tests or procedures that would otherwise not be performed as part of your normal care at no cost to you. You or your insurance company will be responsible for all other costs. You should check with your insurance company regarding coverage that will apply in connection with your participation in this trial.
If you choose to take part in the TRACTION-2 trial, we encourage you to communicate openly and honestly throughout the trial. If you have questions or concerns about any aspect of the trial at any time, you should talk with the trial doctor, trial staff, or your doctor.