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

NCT ID: NCT04950114

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-11-02

Brief Summary

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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)

Detailed Description

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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).

Conditions

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Kidney Diseases Glomerulosclerosis Focal Segmental Nephrosis Lipoid Urologic Disease Glomerulonephritis Nephritis Nephrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label study extension
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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200 mg Dose Cohort

Participants 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.

Group Type EXPERIMENTAL

GFB-887

Intervention Type DRUG

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

Interventions

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GFB-887

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goldfinch Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academic Medical Research Institute (AMRI)

Los Angeles, California, United States

Site Status

Amicis Research Center

Northridge, California, United States

Site Status

Kidney and Hypertension Center - Apple Valley

Victorville, California, United States

Site Status

University of Colorado Anschutz Medical Center

Aurora, Colorado, United States

Site Status

Colorado Kidney Care (Denver Nephrology)

Denver, Colorado, United States

Site Status

Boise Kidney and Hypertension Institute

Nampa, Idaho, United States

Site Status

NANI Research, LLC

Hinsdale, Illinois, United States

Site Status

St. Clair Nephrology

Roseville, Michigan, United States

Site Status

Clinical Research Consultants

Kansas City, Missouri, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Site Status

Prolato Clinical Research Center

Houston, Texas, United States

Site Status

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Site Status

Tranquility Research

Webster, Texas, United States

Site Status

Utah Kidney Center

Salt Lake City, Utah, United States

Site Status

Providence Medical Research Center

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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GFB-887-202

Identifier Type: -

Identifier Source: org_study_id

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