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

Primary Purpose

Kidney Diseases, Glomerulosclerosis, Focal Segmental Nephrosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GFB-887
Sponsored by
Goldfinch Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Research Institute (AMRI)
  • Amicis Research Center
  • Kidney and Hypertension Center - Apple Valley
  • University of Colorado Anschutz Medical Center
  • Colorado Kidney Care (Denver Nephrology)
  • Boise Kidney and Hypertension Institute
  • NANI Research, LLC
  • St. Clair Nephrology
  • Clinical Research Consultants
  • Icahn School of Medicine at Mount Sinai
  • The Ohio State University Wexner Medical Center
  • Southeast Renal Research Institute
  • Prolato Clinical Research Center
  • Clinical Advancement Center, PLLC
  • Tranquility Research
  • Utah Kidney Center
  • Providence Medical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

200 mg Dose Cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events
Incidence and severity of adverse events

Secondary Outcome Measures

Percent reduction in urine protein:creatinine ratio (UPCR) from baseline
Percent reduction in urine protein:creatinine ratio (UPCR) from baseline
Proportion of participants achieving modified partial remission status
Proportion of participants achieving modified partial remission status
Proportion of participants achieving complete remission status
Proportion of participants achieving complete remission status
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
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
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
Time to maximal percent reduction in UPCR from baseline
Time to maximal percent reduction in UPCR from baseline
Summary of plasma pharmacokinetic (PK) concentrations: Dose proportionality
Dose proportionality of GFB-887
Summary of Plasma PK concentrations (AUCinf)
Area under the plasma concentration-time curve from time zero to infinity
Summary of Plasma PK concentrations (AUClast)
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Summary of Plasma PK concentrations (Cmax)
Maximum observed plasma concentration
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

Full Information

First Posted
June 25, 2021
Last Updated
November 10, 2022
Sponsor
Goldfinch Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04950114
Brief Title
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
Official Title
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Goldfinch Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Glomerulosclerosis, Focal Segmental Nephrosis, Lipoid Urologic Disease, Glomerulonephritis, Nephritis, Nephrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label study extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200 mg Dose Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GFB-887
Intervention Description
GFB-887 is a potent, small molecule inhibitor of TRPC5.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
Percent reduction in urine protein:creatinine ratio (UPCR) from baseline
Description
Percent reduction in urine protein:creatinine ratio (UPCR) from baseline
Time Frame
Approximately 3 years
Title
Proportion of participants achieving modified partial remission status
Description
Proportion of participants achieving modified partial remission status
Time Frame
Approximately 3 years
Title
Proportion of participants achieving complete remission status
Description
Proportion of participants achieving complete remission status
Time Frame
Approximately 3 years
Title
Proportion of participants with a UPCR decrease of at least 30% from baseline
Description
Proportion of participants with a UPCR decrease of at least 30% from baseline
Time Frame
Approximately 3 years
Title
Proportion of participants with a UPCR decrease of at least 40% from baseline
Description
Proportion of participants with a UPCR decrease of at least 40% from baseline
Time Frame
Approximately 3 years
Title
Proportion of participants with a UPCR decrease of at least 50% from baseline
Description
Proportion of participants with a UPCR decrease of at least 50% from baseline
Time Frame
Approximately 3 years
Title
Time to maximal percent reduction in UPCR from baseline
Description
Time to maximal percent reduction in UPCR from baseline
Time Frame
Approximately 3 years
Title
Summary of plasma pharmacokinetic (PK) concentrations: Dose proportionality
Description
Dose proportionality of GFB-887
Time Frame
Approximately 3 years
Title
Summary of Plasma PK concentrations (AUCinf)
Description
Area under the plasma concentration-time curve from time zero to infinity
Time Frame
Approximately 3 years
Title
Summary of Plasma PK concentrations (AUClast)
Description
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Time Frame
Approximately 3 years
Title
Summary of Plasma PK concentrations (Cmax)
Description
Maximum observed plasma concentration
Time Frame
Approximately 3 years
Title
Changes in estimated glomerular filtration rate (eGFR) including slope
Description
Glomerular filtration rate will be estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on serum creatinine
Time Frame
Approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Academic Medical Research Institute (AMRI)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Amicis Research Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Kidney and Hypertension Center - Apple Valley
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
University of Colorado Anschutz Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Kidney Care (Denver Nephrology)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
NANI Research, LLC
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
St. Clair Nephrology
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-2743
Country
United States
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Tranquility Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Utah Kidney Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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