Overview

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

Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Goldfinch Bio, Inc.
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