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Kidney DiseasesPhase 2NCT04950114

An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases

A Phase 2 study testing GFB-887 in people with Kidney Diseases and Glomerulosclerosis, run by Goldfinch Bio, Inc. at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label Phase 2 study evaluating the long term safety and tolerability of GFB-887 in patients with focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GFB-887
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
17 sitesUnited States
Study dates
27 Jul 2021to 2 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with FSGS/TR-MCD who have completed the treatment phase from an interventional clinical study with GFB-887. Participants who were discontinued for rising proteinuria from a GFB-887 interventional study may be considered for enrollment following consultation with the Medical Monitor.
  • Participants who enrolled in any other interventional study during the time between completion of the prior GFB-887 interventional study and this study may be considered for enrollment following consultation with the Medical Monitor.

Who cannot join

  • Participant is unable to take oral medications
  • Participant has an unstable medical condition based on medical history, physical examination, laboratory tests, ECGs, vital signs or is otherwise unstable in the judgement of the Investigator which would pose a risk to the participant or interfere with study evaluation, procedures, or completion
  • Evidence of significant hypersensitivity, intolerance, or allergy to any component of investigational product GFB-887

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Colorado Anschutz Medical Center

    Aurora, Colorado, 80045

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404-2743

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Colorado Kidney Care (Denver Nephrology)

    Denver, Colorado, 80230

  • NANI Research, LLC

    Hinsdale, Illinois, 60521

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Clinical Research Consultants

    Kansas City, Missouri, 64111

  • Academic Medical Research Institute (AMRI)

    Los Angeles, California, 90022

  • Boise Kidney and Hypertension Institute

    Nampa, Idaho, 83687

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Amicis Research Center

    Northridge, California, 91324

  • St. Clair Nephrology

    Roseville, Michigan, 48066

  • Utah Kidney Center

    Salt Lake City, Utah, 84115

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Kidney and Hypertension Center - Apple Valley

    Victorville, California, 92395

  • Tranquility Research

    Webster, Texas, 77598

Other trials in United States

About this study

This is an open-label Phase 2 study evaluating the long term safety and tolerability of GFB-887 in patients with focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD)

Read the detailed description

Participants will be enrolled from the ongoing GFB-887 multiple ascending dose trial. Participants will be transitioned to a 200 mg QD dose level regardless of the dose received in the previous study although the data review team (DRT) and Medical Monitor may elect to decrease or increase the dose to minimize adverse events or improve clinical efficacy. The DRT may also elect to change dosing levels due to emerging data on GFB-887. Participants will take GFB-887 once daily at home. A phone visit will be conducted at Week 4 and at Week 8 to assess safety and tolerability. Participants will return to the clinic for follow up visits at Weeks 12, 24, 36, 48, and every 24 weeks thereafter through approximately 3 years from the time of the participant's first dose to evaluate long-term safety and durability of response (for up to approximately 13 scheduled in-clinic visits).

Being tested
GFB-887
Medical subject headings
Kidney Diseases, Glomerulonephritis, Nephritis, Nephrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GFB-887Drug

    GFB-887 is a potent, small molecule inhibitor of TRPC5.

Study groups in NCT04950114
Study groupRoleWhat they receive
200 mg Dose CohortExperimentalParticipants who received GFB-887 or placebo in GFB-887-201 will receive GFB-887 at a daily dose level of 200 mg regardless of original dose level.
Receives: Drug: GFB-887

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Incidence and severity of adverse events

    Measured: Approximately 3 years

Secondary outcomes (12)

  1. Percent reduction in urine protein:creatinine ratio (UPCR) from baseline

    Percent reduction in urine protein:creatinine ratio (UPCR) from baseline

    Measured: Approximately 3 years

  2. Proportion of participants achieving modified partial remission status

    Proportion of participants achieving modified partial remission status

    Measured: Approximately 3 years

  3. Proportion of participants achieving complete remission status

    Proportion of participants achieving complete remission status

    Measured: Approximately 3 years

  4. Proportion of participants with a UPCR decrease of at least 30% from baseline

    Proportion of participants with a UPCR decrease of at least 30% from baseline

    Measured: Approximately 3 years

  5. Proportion of participants with a UPCR decrease of at least 40% from baseline

    Proportion of participants with a UPCR decrease of at least 40% from baseline

    Measured: Approximately 3 years

  6. Proportion of participants with a UPCR decrease of at least 50% from baseline

    Proportion of participants with a UPCR decrease of at least 50% from baseline

    Measured: Approximately 3 years

  7. Time to maximal percent reduction in UPCR from baseline

    Time to maximal percent reduction in UPCR from baseline

    Measured: Approximately 3 years

  8. Summary of plasma pharmacokinetic (PK) concentrations: Dose proportionality

    Dose proportionality of GFB-887

    Measured: Approximately 3 years

  9. Summary of Plasma PK concentrations (AUCinf)

    Area under the plasma concentration-time curve from time zero to infinity

    Measured: Approximately 3 years

  10. Summary of Plasma PK concentrations (AUClast)

    Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

    Measured: Approximately 3 years

  11. Summary of Plasma PK concentrations (Cmax)

    Maximum observed plasma concentration

    Measured: Approximately 3 years

  12. Changes in estimated glomerular filtration rate (eGFR) including slope

    Glomerular filtration rate will be estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on serum creatinine

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start27 Jul 2021
  3. Primary completion2 Nov 2022
  4. Study completion2 Nov 2022

Why it stopped: Business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label study extension
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950114
Sponsor's protocol ID
GFB-887-202
Status last verified
Nov 2022
First submitted
25 Jun 2021
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GFB-887 in people with Kidney Diseases and Glomerulosclerosis, run by Goldfinch Bio, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04950114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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