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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04950114
• Other study ID #: GFB-887-202
• Status: Terminated
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: November 2, 2022

Study information

• Verified date: November 2022
• Source: Goldfinch Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulosclerosis
• Kidney Diseases
• Nephritis
• Nephrosis
• Nephrotic Syndrome
• Urologic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Center	Aurora	Colorado
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Colorado Kidney Care (Denver Nephrology)	Denver	Colorado
United States	NANI Research, LLC	Hinsdale	Illinois
United States	Prolato Clinical Research Center	Houston	Texas
United States	Clinical Research Consultants	Kansas City	Missouri
United States	Academic Medical Research Institute (AMRI)	Los Angeles	California
United States	Boise Kidney and Hypertension Institute	Nampa	Idaho
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Amicis Research Center	Northridge	California
United States	St. Clair Nephrology	Roseville	Michigan
United States	Utah Kidney Center	Salt Lake City	Utah
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	Providence Medical Research Center	Spokane	Washington
United States	Kidney and Hypertension Center - Apple Valley	Victorville	California
United States	Tranquility Research	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Goldfinch Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events	Incidence and severity of adverse events	Approximately 3 years
Secondary	Percent reduction in urine protein:creatinine ratio (UPCR) from baseline	Percent reduction in urine protein:creatinine ratio (UPCR) from baseline	Approximately 3 years
Secondary	Proportion of participants achieving modified partial remission status	Proportion of participants achieving modified partial remission status	Approximately 3 years
Secondary	Proportion of participants achieving complete remission status	Proportion of participants achieving complete remission status	Approximately 3 years
Secondary	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	Approximately 3 years
Secondary	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	Approximately 3 years
Secondary	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	Approximately 3 years
Secondary	Time to maximal percent reduction in UPCR from baseline	Time to maximal percent reduction in UPCR from baseline	Approximately 3 years
Secondary	Summary of plasma pharmacokinetic (PK) concentrations: Dose proportionality	Dose proportionality of GFB-887	Approximately 3 years
Secondary	Summary of Plasma PK concentrations (AUCinf)	Area under the plasma concentration-time curve from time zero to infinity	Approximately 3 years
Secondary	Summary of Plasma PK concentrations (AUClast)	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration	Approximately 3 years
Secondary	Summary of Plasma PK concentrations (Cmax)	Maximum observed plasma concentration	Approximately 3 years
Secondary	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	Approximately 3 years